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THE NATIONAL PANDEMIC INFLUENZA

PREPAREDNESS AND RESPONSE PLAN: IS THE

UNITED STATES READY FOR AVIAN FLU?

HEARING

BEFORE THE

COMMITTEE ON

GOVERNMENT REFORM

HOUSE OF REPRESENTATIVES

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

NOVEMBER 4, 2005

Serial No. 109–94

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

JON C. PORTER, Nevada

KENNY MARCHANT, Texas

LYNN A. WESTMORELAND, Georgia

PATRICK T. MCHENRY, North Carolina

CHARLES W. DENT, Pennsylvania

VIRGINIA FOXX, North Carolina

JEAN SCHMIDT, Ohio

——— ———

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 November 4, 2005 ........................................................................ 1

Statement of:

Leavitt, Michael O., Secretary, Department of Health and Human Services, accompanied by Dr. Anthony S. Fauci, Director, National Institute

of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services; Dr. Bruce Gellin, Director,

National Vaccine Planning Office, Department of Health and Human

Services; Dr. Julie Gerberding, Director, Centers for Disease Control

and Prevention, Department of Health and Human Services; and Dr.

William Raub, Science Advisor to the Secretary, Department of Health

and Human Services ..................................................................................... 43

Letters, statements, etc., submitted for the record by:

Cannon, Hon. Chris, a Representative in Congress from the State of

Utah, prepared statement of ........................................................................ 40

Cummings, Hon. Elijah E., a Representative in Congress from the State

of Maryland, prepared statement of ............................................................ 35

Davis, Chairman Tom, a Representative in Congress from the State of

Virginia, prepared statement of ................................................................... 4

Gutknecht, Hon. Gil, a Representative in Congress from the State of

Minnesota, Letter dated October 24, 2005 .................................................. 72

Leavitt, Michael O., Secretary, Department of Health and Human Services, prepared statement of .......................................................................... 47

Porter, Hon. Jon C., a Representative in Congress from the State of

Nevada, prepared statement of .................................................................... 99

Schmidt, Hon. Jean, a Representative in Congress from the State of

Ohio, prepared statement of ........................................................................ 100

Waxman, Hon. Henry A., a Representative in Congress from the State

of California:

Fact sheet ................................................................................................... 7

Prepared statement of ............................................................................... 17

(1)

THE NATIONAL PANDEMIC INFLUENZA

PREPAREDNESS AND RESPONSE PLAN: IS

THE UNITED STATES READY FOR AVIAN

FLU?

FRIDAY, NOVEMBER 4, 2005

HOUSE OF REPRESENTATIVES,

COMMITTEE ON GOVERNMENT REFORM,

Washington, DC.

The committee met, pursuant to notice, at 10 a.m., in room 2154,

Rayburn House Office Building, Hon. Tom Davis (chairman of the

committee) presiding.

Present: Representatives Tom Davis, Shays, Burton, RosLehtinen, Gutknecht, Souder, Cannon, Duncan, Miller, Marchant,

Schmidt, Waxman, Lantos, Kanjorski, Sanders, Cummings,

Kucinich, Clay, Watson, Lynch, Van Hollen, Ruppersberger, Higgins, and Norton.

Staff present: Melissa Wojciak, staff director; David Marin, deputy staff director/communications director; Jennifer Safavian, chief

counsel for oversight and investigations; Howie Denis and Anne

Marie Turner, counsels; Rob White, press secretary; Drew Crockett,

deputy director of communications; Susie Schulte, professional staff

member; Sarah D’Orsie, deputy clerk; Allyson Blandford, office

manager; Andrew James, staff assistant; Phil Barnett, minority

staff director/chief counsel; Kristin Amerling, minority general

counsel; Sarah Despres and Robin Appleberry, minority counsels;

Josh Sharfstein, minority health policy advisor; Earley Green, minority chief clerk; and Stacey Warady, minority staff assistant.

Chairman TOM DAVIS. The committee will come to order.

Good morning. Today, we are honored to have Secretary Michael

O. Leavitt here to discuss what health experts describe as the largest public health threat facing our Nation, the threat of pandemic

flu.

We don’t know when, or where, the next pandemic will strike.

We don’t even know what strain of influenza will be the culprit, although much evidence points to avian flu. The virulent H5N1

strain has already caused 62 deaths in Vietnam and Cambodia,

Thailand and Indonesia. Nor do we know if avian flu will turn out

to be more like the swine flu, a pandemic that never materialized.

Regardless, we need to improve your readiness because we can

be sure the next flu pandemic is a matter of when and not if. And

when that time does come, the stakes will be enormous. The Spanish influenza outbreak of 1918–1919, for example, caused an estimated 40 to 50 million deaths worldwide. Experts have projected

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that more than half a million Americans could die, and over 2 million could be hospitalized in the event of a U.S. pandemic flu outbreak.

How quickly could an influenza pandemic spread across the

globe? As fast as you can fly from Hanoi to Washington, DC. We

live in a flat world, a world not only connected by e-mail carried

by fiber-optic cables, but by commerce and cargo transported by

jumbo jets. Pandemic flu can move just as fast.

As Federal officials, it is our responsibility to make sure America

is prepared—prepared to detect the strain of pandemic flu, prepared to communicate with our State and local partners, and prepared to work with industry to get vaccine production moving as

quickly as possible.

Earlier this week, President Bush outlined the administration’s

national strategy for pandemic influenza. The three pillars of this

strategy are preparedness and communication, surveillance and detection, and response and containment. The strategy allows the

government to make immediate steps to ensure early warning

against the possibility of a flu pandemic. The President has requested more than $7 billion in emergency

funding to begin immediately implementing this national strategy.

This includes nearly $3 billion to accelerate the development of cell

culture technology, to move vaccine production away from the

lengthy and fragile process that depends on cultivating the vaccine

in chicken eggs, $1.5 billion to stockpile the H5N1 vaccine currently in clinical trials at NIH, and $1 billion to stockpile antiviral

drugs to treat first responders and our most vulnerable populations.

Additionally, the strategy requests $580 million for pandemic preparedness and about $100 million to help States complete and

exercise their pandemic plans. The strategy also calls for improving

our detection capabilities, train personnel, and additional planning

at both Federal and local levels.

While finalizing the HHS pandemic influenza plan was important and necessary to provide more detailed guidance to State and

local health officials, many concerns about preparedness still remain. I have already heard concerns from the Department of

Health in my home State of Virginia about the limited amount of

money for stockpiling the federally recommended amounts of the

antiviral treatments and the need for additional support across the

board for emergency preparedness.

I think all of us here today agree that our State and local health

officials will be on the front lines of a pandemic response. It is our

job to provide them with the adequate support and essential resources they need to effectively prepare for and respond to a pandemic.

Today’s Washington Post applauds the administration for, ‘‘taking preparedness seriously.’’ But the editorial also says, ‘‘the plan

seems divorced from reality’’ and ‘‘is too vague to be reassuring.’’

This morning we will search for reality-based details in the hope

of reassuring all Americans that we are on the road to preparedness.

I look forward to a constructive dialog with Secretary Leavitt on

this life-and-death issue. I think the National Strategy and HHS

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Pandemic Influenza Plan will offer appropriate guidance and help

better prepare our country for the unknowns of pandemic flu. However, as the Secretary has mentioned before, we need to remember

that the plan is a living and breathing document subject to improvement as we develop better strategies and practices.

I would now recognize our distinguished ranking member who

has been so active in the field of health, Mr. Waxman, for his opening statement.

[The prepared statement of Chairman Tom Davis follows:]

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Mr. WAXMAN. Thank you very much, Chairman Davis, for calling

today’s hearing on the serious public health threat of a potential

global influenza pandemic. And under your leadership, this will be

this committee’s seventh hearing related to a flu pandemic.

As those who have followed our hearings know, I have been extraordinarily critical of the administration’s failure to prepare for

a pandemic. Recently, my staff put together an analysis of these

delays and mistakes that have characterized the Federal effort over

the last 5 years, and I ask for unanimous consent that this analysis

be made part of the record.

Mr. SHAYS [presiding]. Without objection, so ordered.

[The information referred to follows:]

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Mr. WAXMAN. What we document is that the Department of

Health and Human Services and the White House have ignored report after report and warning after warning.

Four years ago, the Institute of Medicine urged the administration to create a national vaccine authority to coordinate a highlevel response to a growing crisis in vaccine supply. This was an

extraordinary recommendation made by a group of experts that included Dr. Anthony Fauci of the National Institutes of Health. Yet

today these crucial recommendations still have not been implemented.

Three years ago, the National Vaccine Advisory Committee to the

Department of HHS recommended that the administration enhance

incentives to spur vaccine development and support the vaccine

market. Yet nothing was done.

The front lines of fighting a flu pandemic are our State and local

health departments, but the President’s budget proposals repeatedly try to cut their funding. The result is that we have fallen significantly behind in our efforts to protect against the bird flu or

other global pandemics.

Our Nation—other nations have released comprehensive plans

and purchased significant quantities of antiviral drugs. Because of

our delays we are at the back of the line. At last, however, some

progress is being made. On Tuesday, the President announced a

significant new proposal for funding influenza vaccine development

and procurement. Then, on Wednesday, the Department of Health

and Human Services released a detailed plan to guide Federal,

State and local preparations.

These are important steps. And even as I wish they had been

taking taken sooner, I commend the President and Secretary

Leavitt for acting now. And we will all be safer if the events of this

week become a turning point.

There are parts of the President’s strategy that make a lot of

sense. He has proposed investing in the next generation of flu vaccines which can be produced quickly and safely. He has also released a plan that provides important guidance to State and local

health departments and laboratories.

But unfortunately, there are also some significant problems. The

administration has given a key role to the Department of Homeland Security and FEMA to protect the Nation from a localized outbreak of pandemic flu in the United States. But given the abysmal

performance of the Department of Homeland Security and FEMA

in responding to Hurricane Katrina, this is a huge misjudgment.

Protecting the public from a pandemic is a health problem, and it

should be given to the government’s health experts.

Another serious problem is inadequate funding. The administration has produced a detailed plan that instructs local and State

governments to perform literally hundreds of tasks to prepare for

an influenza pandemic, yet the administration is asking Congress

for only $100 million to fund these activities. And even this $100

million increase is a phony number. The White House has not retracted its $130 million cut to State and local health departments.

Moreover, the administration is also asking States and localities

to spend $510 million of their own money to purchase antiviral

medications. As one health department director put it, ‘‘There

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seems to be a lack of connection between the strategy and recognition of what it takes to pull off these plans on the ground.’’

A third problem is the administration’s plan to shield vaccine

manufacturers from liability without providing any meaningful

compensation for people who are injured by the vaccine. We have

learned during the administration’s failed efforts to vaccinate several million health care workers, fire fighters and other first responders that a liability shield will not work unless those who

might be injured by a vaccine know they will receive compensation.

Yet the administration is poised to make the same mistake all over

again.

These are serious problems, but they can be fixed; and I look forward to discussing these issues with Secretary Leavitt today. I

thank him for his appearance. I hope this oversight hearing produces real improvements in public health preparedness for the benefit of the American people.

[The prepared statement of Hon. Henry A. Waxman follows:]

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Chairman TOM DAVIS. Mr. Waxman, thank you.

All Members will be able to enter statements into the record. I

know there are some who want to speak now. I would just add, the

Secretary has limited time so to the extent we are speaking, we

won’t be able to get maybe through all the questions, but I don’t

want to deprive anyone of making an opening statement.

Mr. Gutknecht, I know you wanted to say something.

Mr. GUTKNECHT. Mr. Chairman, ever so briefly. And I want to

thank you for this hearing and I want to thank the Secretary for

coming up here today.

I really think that one of the issues that I hope we will discuss

today is the issue of duplication of efforts. Because I know that

there are efforts going on in labs in my district, for example, that

I think are very interesting; and my concern is that, ultimately, the

Federal Government may wind up duplicating an awful lot of the

good work that is being done right now. And so I think this is a

very important issue.

The public is deeply concerned, but I think they also want us to

be accountable for the money we spend. And so as we have this

hearing I hope that issue will at least get some consideration.

I would yield back.

Chairman TOM DAVIS. Mr. Lantos.

Mr. LANTOS. Thank you, Mr. Chairman.

I want to welcome this distinguished panel. And I would like to

raise some specific issues which relate to the geographic pattern of

our preparedness.

One of the very severe problems we had in responding to September 11th was that, following historic patterns, we provided

funding and made preparations on a nationwide basis, disregarding

the fact that some areas are dramatically more likely to be targets

of terrorist attacks than others.

Now, Mr. Chairman, the San Francisco International Airport is

at the heart of my congressional district. And it is self-evident that

this flu epidemic, generating in Asia, is most likely to hit, initially,

the three major points of entry on the Pacific coast—San Francisco

International Airport, Los Angeles, and Seattle.

Last year, Mr. Chairman, 32 million passengers came through

San Francisco International Airport. Over 3 million of these individuals came from Asia. A similar number landed in Los Angeles

and a smaller number in Seattle.

Now, the 1918 flu epidemic, which was responsible for the death

of over 50 million people, circled the globe several times in 18

months, which was an amazing feat given the fact that we were a

generation away from commercial air travel. Just consider what

kind of devastation such a virus could unleash, given the enormous

presence of global air travel.

I know that deadly airborne illnesses are not novel for San Francisco International Airport. I remember going down to the airport

to catch a flight and seeing passengers arriving from Asia with

medical masks, in 2003 during the SARS outbreak.

What I would like to ask Secretary Leavitt and his distinguished

panel to tell us is, what specific provisions do you have in mind?

What specific plans do you have to deal with the most likely initial

points of entry with respect to quarantine and a dozen other items?

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And I very much hope that in planning for this potential pandemic we will not make the mistake we did after September 11th,

of assuming that Laramie, WY, is as likely to be hit as New York

or San Francisco.

This pandemic, if it comes, is most likely to come from Asia, it

is most likely to come via San Francisco, Los Angeles or other ports

of entry; and I would be most appreciative if you could deal with

this issue.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you, Mr. Lantos.

Yes, Mr. Duncan.

Mr. DUNCAN. Very briefly, Mr. Chairman, I thank you for calling

this hearing; and I think it is very important that we look into this

entire bird flu situation. However, I do have concerns and questions about whether we are overreacting because of breathless,

overdramatized news reports, repeated over and over again in our

24-hour news cycles.

Have we turned something into a pandemic before it is even an

epidemic? In fact, almost every major disease known to man kills

more people around the world every day than this bird flu has in

the last several months.

Now, from what I read, we are about to spend billions on a vaccine or medicine that we are not even sure will work on this particular virus. We have already scared people around the world so

much that they are hoarding Tamiflu medicine that may or may

not even help with this particular flu.

I am not a medical doctor or a public health specialist I am not

saying we should do nothing. All I am saying is that possibly we

should look before we leap. In today’s political climate, almost

every threat is exaggerated, and then legislators have to try to do

everything possible to prove that they are doing more than anyone

else in case something does happen.

I led a congressional delegation to Asia last February when we

went into the Hong Kong airport. They immediately checked the

temperatures of everybody in our delegation. Are we checking all

those who are coming from countries where, or areas where, the

bird flu has appeared and/or should we?

Again, I will say that I am not saying we should do nothing. All

I am saying is that we should not panic before the facts are justified. We need all those in authority to ask many questions and

take reasonable common-sense and intelligent steps to sensibly

deal with this situation.

Thank you.

Chairman TOM DAVIS. Thank you very much.

Mr. Kucinich.

Mr. KUCINICH. Thank you, Mr. Chairman.

Is the United States ready for avian flu? I don’t think that there

is any question that the answer is a clear ‘‘no.’’ The question is

what are we doing about it?

The administration finally released its plan this week under tremendous public pressure. It got overwhelming reviews—excuse me,

it got underwhelming reviews from experts because it is deficient

on several fronts that will be collectively necessary for us to fight

this disease.

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It is especially weak on efforts to stockpile antivirals. Our best

antiviral bet will be Roche’s Tamiflu. It is well established that it

will take Roche years to produce enough American stockpile needs

and—to produce enough to satisfy American stockpile needs. We

have enough for less than 1 percent of the population. We need at

least enough for 25 percent of the population.

Even after promised increases in production capacity, Roche’s

supply is far less than our stockpile needs. The same goes for countries around the world, including those where the outbreak is likely

to originate if the virus mutates to pass easily from human to

human. And yet there are plenty of production facilities to solve

the problem. In fact, over 100 companies have expressed interest

in making the drug.

So what is the problem? The problem is that Roche has a monopoly on Tamiflu.

We are very familiar with what happens when a company has a

monopoly on a product the world needs. They control supply. And

that is exactly what Roche is doing by choking world supply. And

what is happening by choking world supply is not the only consequence of Roche’s monopoly. If we need a reminder about the perils of concentrating production in the hands of a few, we only need

to look to last year.

Chiron was forced to scrap half of the U.S. flu vaccine supply

when their manufacturing facility failed to meet safety standards.

That was for the conventional flu. Imagine what would happen if

we lost half of our Tamiflu supply in the middle of an avian flu outbreak? And yet, at the cost of a potentially far more devastating

avian flu pandemic, we are about to repeat our mistake.

But there is a solution. The solution is compulsory licensing.

HHS, Mr. Secretary, has the authority to issue a compulsory license to get rid of this dangerous shortage by allowing other companies to make Tamiflu. Roche would get compensation. That authority exists specifically to prevent the most predictable scenario,

a pharmaceutical company holding a drug hostage when it is needed to protect public health in order to increase its profits. And I

believe that is what we are seeing here.

Roche’s revenues increased 17 percent last quarter. Tamiflu sales

more than doubled to 215 million in 3 months. They expect to

make only almost $1 billion from Tamiflu sales this year. Of

course, they would want to hang on to this monopoly; their ultimate responsibility is to their shareholders, not to the public.

We have heard a lot of promises from Roche that they are willing

to negotiate with other companies to sublicense production, but I

have not heard anything about a firm agreement to do so. Roche

can keep fees too high in order to make it unprofitable for an outside company to manufacture Tamiflu. They can stipulate—and

have indicated their willingness to do so—that any Tamiflu made

by a company other than Roche would not be available for sale in

the United States. In other words, they can continue to restrict

supply.

And to top it off, the administration boasts it wants throw $1 billion into buying antivirals. But the drugs aren’t there. There is

nothing to buy. And as it stands, there won’t be anything to buy

in the near future. We may not have that kind of time. But the adVerDate 11-MAY-2000 14:57 Apr 02, 2006 Jkt 000000 PO 00000 Frm 00028 Fmt 6633 Sfmt 6633 D:\DOCS\24820.TXT HGOVREF1 PsN: HGOVREF1
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ministration is still sitting on its hands while Roche’s profits skyrocket and Tamiflu production does not.

This is a clear choice of profits over public health.

As you know, Mr. Secretary, last month nine of my colleagues

and I sent you a letter requesting compulsory licensing. We have

given Roche plenty of time to act appropriately, and they have

failed to do so.

In order to protect public health, we must issue a compulsory license for Tamiflu immediately.

I thank the Chair.

Chairman TOM DAVIS. Mr. Souder.

Mr. SOUDER. Thank you. I am grateful to Chairman Tom Davis

for holding this important hearing as part of a series of hearings

with Secretary Leavitt on our country’s preparedness and response

plan for the pandemic influenza.

Earlier this week, the President announced a National Strategy

for Pandemic Influenza and Health and Human Services published

its Pandemic Influenza Plan. These developments are encouraging

signs that the administration is taking seriously the potential devastation of a new pandemic.

As stated in the HHS Pandemic Influenza Plan, ‘‘Preparedness

planning is imperative to lessen the impact of a pandemic.’’ I

couldn’t agree more. We should not have to relearn again and

again that being caught unprepared for a predictable disaster

makes an otherwise manageable situation spiral out of control. So

while I commend the Secretary of Health and Human Services for

attempting to get ahead of a possible influenza pandemic, I remain

skeptical of the agency’s ability to identify and respond to danger

signals indicating a genuine national problem.

This country is already struggling with a serious epidemic, methamphetamine abuse and trafficking. This epidemic is already in

every State viscously destroying lives and tearing apart communities. This national epidemic, however, is one in which HHS,

under Secretary Leavitt’s leadership, stood as a barrier for formulating a national comprehensive strategy to address this problem.

As this destructive epidemic was spreading, Congress was constantly asking the administration for a national plan to address

this epidemic. But it was the HHS Secretary who was dragging his

feet. The so-called ‘‘policy’’ that was finally announced at an August

press conference—not in Washington, DC, but in Tennessee—after

years of devastation and countless lives, is insufficient and hardly

deserves to be called a national plan to address the epidemic. It

was embarrassing.

Mr. Secretary, I would like you to show this committee and the

American people that we can have confidence in the ability of the

Nation’s health agency to do more than talk about an epidemic.

This kind of lip service we have received in the midst of a meth

epidemic had better give way to real, effective planning and treatment for an influenza pandemic, or the inevitable devastation could

be the worst this country has ever experienced.

I would like to add, I was just given your response to my letter

of August 19th. And I appreciate receiving the response. In the future, as someone who represents the same party and as chairman

of the subcommittee, I would hope it wouldn’t take the full commitVerDate 11-MAY-2000 14:57 Apr 02, 2006 Jkt 000000 PO 00000 Frm 00029 Fmt 6633 Sfmt 6633 D:\DOCS\24820.TXT HGOVREF1 PsN: HGOVREF1
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tee chairman having you at a hearing to get a timely response to

questions.

I yield back.

Chairman TOM DAVIS. Thank you.

Mr. Sanders.

Mr. SANDERS. Thank you very much, Mr. Chairman. And Secretary Leavitt, thanks very much for being with us.

Mr. Chairman, I think perhaps Mr. Duncan was right in suggesting that we may be overreacting. But I believe that the American

people want us to be safe rather than sorry. I think they will forgive us if we end up doing things and spending money, and in the

long run it may turn out not to be necessary. If, in fact, we are

going forward vigorously to prevent what could be a horrible, horrible situation.

I think we all remember, or read, that in 1918 some 50 million

people in this world died from an influenza epidemic. And I think

it is beholden upon our country and governments throughout the

world to do everything that we can in every way to protect the

American people and people throughout the world.

I think Mr. Kucinich a moment ago raised some very important

issues. And the issue is that our job as the Government of the

United States of America is not to worry at this moment about the

corporate profits of the Roche company, or any other drug company, but to make certain that we are doing all that we can to prepare for what could be a terrible pandemic.

I hope that in that context we can all agree that now is not the

time to be tiptoeing around intellectual property rights or letting

bald-faced profiteering inhibit our ability to prepare for a pandemic.

This, in fact, is a matter of life and death. And the American people will never forgive us if we are not prepared and if we allow corporate profiteering to take the place of serious government action.

I think most of us understand that one of the important tools

that we now have at our disposal is getting caught up in that hemming and hawing about whether or not we go forward in terms of

dealing with Roche.

Tamiflu, as we all know, is the brand name of an antiviral medicine that is what we have right now for minimizing the scope and

severity of damage from a pandemic flu outbreak. While we all, no

doubt, support vigorous pursuit of an avian flu vaccine, antivirals

are what we have got today, right now. But we don’t have anywhere near the amount that we need; and I hope that the Secretary will address that important issue.

All the speeches, all the reports are fine. Do we have the medicine that we need and will we have it? The Infectious Diseases Society of America and the World Health Organization say the United

States should have enough courses to treat from 25 to 40 percent

of the population—our population. Right now, the United States

only has enough to cover 1 to 2 percent of the population.

So that is an issue I hope that you will address, sir, when you

speak.

Roche is the only company with a license to manufacture and sell

Tamiflu in the United States. They have limited production capacity and simply cannot make enough Tamiflu to meet the demand.

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The World Health Organization says it will take 10 years for Roche

to adequately supply world demand for Tamiflu stockpiles. We

don’t have 10 years. Unfortunately, Roche has also been dragging

its feet about licensing other manufacturers to mass produce it.

So, Mr. Secretary, you come from an administration which, most

of the American people know, bends over backward to protect large

multinational corporations, whether it is drug companies or oil

companies. Now is not the time to worry about the profits or campaign contributions. Now is the time to protect the American people. If Roche does not have the capability of producing the volume

of Tamiflu that we need, clearly what has to happen is, other companies have to jump in.

I know that Senator Schumer in the Senate has raised that

issue. I hope that you will be able to tell us today that in one way

or another you are going to make certain that Roche, either

through compulsory licensing or through a voluntary approach

working with other production capabilities and other companies,

will start producing the medicine that we need.

This is not the time for a company to be making excessive profits

when the American people do not have the medicine they need to

protect themselves, nor for the world as well. So we hope that you

will be strong in dealing with Roche and saying that the health

and well-being of the American people comes before their corporate

profits.

Thank you very much.

Chairman TOM DAVIS. Mr. Burton.

Mr. BURTON. Thank you, Mr. Chairman.

It is nice seeing all of you again.

First of all, I want to commend the President for making the

speech that he made on protecting ourselves and preparing for a

possible epidemic or pandemic to be very bad not only for the

United States, but for the entire world.

I want to talk about another subject that is very, very important.

And you folks will be making recommendations as well as getting

the job done and helping produce the vaccines that are necessary

to protect the American people.

For about 4 or 5 years, when I was chairman of the committee,

we had hearings on contaminants in vaccines. The one that really

bothered me was the mercury in the vaccine thimerosal. Thimerosal was never tested by the Food and Drug Administration because

it was produced before you guys had the ability to do that. And it’s

been used in vaccines for a long, long time, since the 1930’s.

And when I was a boy growing up, if you had measles, they quarantined you. Now they give you vaccinations for that. And kids get

as many as 30 vaccinations before they go to school. And adults are

getting all kinds of shots. I am ready to go over to Pakistan and

India, and all the people on my CODEL are going to get a whole

series of shots, and almost all of them contain thimerosal, which

has 50 percent ethyl mercury in it.

Now, the reason I bring this up is we have had an epidemic of

autism in this country. We gone from 1 in 10,000 children that are

autistic to 1 in 166, according to CDC. It is an epidemic. We have

had an increase in Alzheimer’s, another neurological disorder. And

people that I had before my committee for years, scientists from

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around the world, said that one of the causes was the mercury in

the vaccines.

And the reason I bring this up is we are going to have to produce

the vaccines that are necessary. You and the pharmaceutical industry are going to have to produce the vaccines. I want to give them

protection against class-action lawsuits, but in exchange for that—

and this President talked about that—tort reform. In exchange for

that, it is extremely important that the Vaccine Injury Compensation Fund be more user-friendly, and we put more money into it

if it is necessary, and that can be done by a small increase in the

costs per shot.

And the second thing is get mercury out of all vaccines. It can

be done if you go to single shot vials or use something else as a

preservative. But the mercury, in the opinion of scientists around

the world, is causing neurological problems, an increase in Alzheimer’s, autism and other things.

Now, you have been very helpful in getting it out of most of the

children’s vaccines. It is still in three or four. Please, when they

start talking about legislation to deal with this, do those three

things: Get mercury out of the vaccines, make the compensation

fund more user-friendly, and then we will do everything we can,

No. 3, to give the pharmaceutical industry the class-action lawsuit

protection that they want.

I want them to produce those vaccines. I want them to keep this

country and the world the safest it has ever been as far as health

is concerned, and I know you feel that way, too. But you can’t leave

these contaminants, especially mercury, which is a known

neurotoxin, in these vaccines. Thank you very much.

Chairman TOM DAVIS. Ms. Norton.

Ms. NORTON. Mr. Chairman, I appreciate that you called this

hearing. I want to welcome the Secretary and others from the Department. Mr. Chairman, in the street they would say, this hearing

is right on time, following the President’s announcement. I wish I

could say that the government’s response here is on time.

I will be looking for answers to a number of questions concerning

pandemic flu, why countries in Europe are more prepared, so that

we may have to get in line behind them and, in fact, may not be

able to get it at all if Europe decides to redirect whatever medicines they have and not allow their suppliers to deal with those

who are offshore, if we get enough of a pandemic. Why there are

large cuts in State and local public health budgets, the very vehicles that we will need in the event of a pandemic?

But if I may say so, I think Mr. Duncan, my colleague across the

aisle, raises a point that may be in the minds of the American people. If this had been an early reaction, if this had been earlier, it

might have been seen as an attempt to get early hold of a pandemic. And now for many Americans it does seem like an overreaction when you consider that apparently we haven’t done first

things first.

I don’t know how Americans are to have confidence in the Department to deal with pandemic flu when already, this early in the

season, we are having distribution problems with the vaccine we

already are supposed to have.

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And I raise it only because I believe it would be legislative malpractice not to raise it when already early in the flu season here

we are seeing pop up problems of distribution all over this region

and across the country. Walgreen’s says they are going to stop

doing it altogether because they don’t have enough supply after November 6th.

We sat through the flu crisis of last year. I was so relieved when,

before I got my shot here, Mr. Secretary, I wanted to make sure

that the priorities were on straight, because the Congress had its

supply when others did not, and I was assured that everybody had

a supply. And here we have seniors standing in line. CDC, of

course, tosses it off as a distribution problem.

The fact is that these are the kinds of problems that we pay you

to make sure we do not have. Part of it is, of course, that you are

victims of our success, although it is not because of your advertising campaign. It is because we ran out last year, and now people

have flu vaccine on their minds, and they rush in to get it. Well,

that was foreseeable, sir. It was foreseeable that this company that

we rely on so heavily for this ordinary, annual vaccine is still on

its knees, still has huge problems that it is not correcting, and yet

they are a major supplier.

There is a huge confidence problem with respect to our ability to

deal with the annual flu, the ordinary illnesses that are ordinary

illnesses that Americans know they will get. It seems to me you

have to get ahold of that problem, not say, oh, it is the distribution,

or, it really isn’t us. You have to tell us how you are going to get

ahold of that problem before you can expect us to have any confidence that you can reach to a problem, which most Americans

can’t possibly take seriously yet because so few people, as Mr. Duncan says, have died. I think that is exactly when you want to get

ahold of it.

But my question to you is why should Americans focus on

pandemics from Asia when they cannot get the ordinary flu vaccine

in the District of Columbia, Maryland, and Virginia and across the

United States of America?

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you.

Any other Members on our side wish to address? How many

other speakers we got here? OK, we will go straight on down the

road.

Mr. Clay.

Mr. CLAY. Thank you, Mr. Chairman and Ranking Member Waxman, for holding today’s hearing.

Given that a flu pandemic today can cause over 500,000 deaths

and 2 million hospitalizations in the United States alone, it is essential that our Nation be prepared to effectively respond to a flu

pandemic.

While I applaud the Bush administration’s efforts to prepare for

the danger of a pandemic flu outbreak, I am concerned that the

President’s strategy underfunds State and local preparedness efforts. The President’ plan requires States to spend $510 million to

purchase antivirals. As we all know, many States’ budgets are already strapped. And where does the President expect them to get

$510 million to afford such a purchase? It is imperative that ConVerDate 11-MAY-2000 14:57 Apr 02, 2006 Jkt 000000 PO 00000 Frm 00033 Fmt 6633 Sfmt 6633 D:\DOCS\24820.TXT HGOVREF1 PsN: HGOVREF1
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gress ensure our constituents that this is not another underfunded

mandate that will later be funded on the backs of poor people.

I welcome Secretary Leavitt and thank him for graciously providing our committee with insight into the steps being taken to stockpile enough vaccine to protect Americans against the bird flu.

It is my hope that today’s hearing will also address recent reports that have indicated a possible repeat of last year’s flu vaccine

shortage.

I yield back and ask that my written statement be included in

the record.

Chairman TOM DAVIS. Without objection, gentleman’s statement

and any other—Mr. Van Hollen.

Mr. VAN HOLLEN. Thank you, Mr. Chairman, I want to thank

you and Mr. Waxman for holding these hearings, and for those of

you who have been following this committee, you know that this is

not the first hearing we have had on this issue. We have had hearings on this issue well over a year ago. And I want to commend

the chairman and Mr. Waxman in trying to get ahead of this issue.

Mr. Secretary, I welcome you and all the others here today and

look forward to your testimony. And I appreciate the fact that the

President has come up with a plan, and I think it has many good

components. I share the view of some of my colleagues expressing

some of what I think are the shortcomings with the plan.

My major concern with the plan has to do with the amount of

resources dedicated to trying to nip the problem in the bud overseas, trying to help our international partners, especially in Asia,

be better prepared to respond to this issue. When we talk about the

war on terrorism, the Bush administration has made a big point

of the fact that it is important to fight the battle overseas before

it comes here. We have to disrupt the terrorist networks overseas

before they have time to organize and launch attacks here on the

shores of the United States. Well, I can’t think of a better case

where it is better to address a problem overseas at its source before

it gets here than the issue of pandemic flu and avian flu. I think

we would all agree that by the time you ever saw this flu exhibiting itself in people here in the United States, it would already have

gotten very much out of control worldwide.

And so I think if you look at the plan that you have put forward,

as I understand it, you have allocated about $251 million to helping some of our partners and friends overseas on this issue. That

is a near 31⁄2 percent of the overall $7-plus billion in this plan. And

if you look at this issue as trying to control things before they get

out of control and trying to identify ways to prevent the spread and

nip things in the bud and at their source, it seems to me that that

is not nearly enough to accomplish that purpose.

Clearly, we want to stockpile drugs here. We want to have the

ability to fight the virus in its current form, the ability to be able

to quickly ramp up so we can meet whatever form it may take in

the future. It is important to have antiviral drugs, but those

stockpilings all assume and plan for the worst case. It seems to me

we should be devoting more resources to preventing the worst case

in terms of prevention at its source, and so I hope during your testimony you will address this.

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I know you traveled to Asia. You have looked at some of the farm

techniques. There has been talk from the United Nations and

World Health Organization about trying to develop something to

put in the feed of chickens that might immunize them, and there

are lots of ideas out there. It just seems to me that the plan that

has being presented is very light on the amount of resources committed to what I think should be a very big focus of this, which is

stopping this problem at its most likely source.

Thank you, Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

Mr. RUPPERSBERGER. I think I am the last one, and then we will

be able to get to the testimony.

Mr. Chairman, thank you for the hearing. Mr. Waxman, thank

you for your leadership.

I am not going to repeat a lot that was said. First thing that we

need to learn from what happened in the past last year with our

flu vaccine shortage, that if we can learn from our mistakes and

move forward, we will be better off.

I think the President, the fact that he is paying attention to this

issue, making it a priority and moving ahead with the plan is good,

but we have to implement the plan right now. I think the fact that

local government is going to really be involved is a good thing because as first responders, they are closest to the people, as long as

they get the resources. And we have discussed that here today also.

My major concern, though, is the issue of how with respect to the

plan, and what is the delivery system?

On the last time you were here, Mr. Secretary, I asked a question about the issue of needles and injection devices, and I have not

received a small response.

And I want to address what Congressman Souder said: We, here,

have an oversight. We are relying on you. We have hearings to

raise issues and to hopefully hold you accountable. My office sent

a letter on October 7th asking about this issue, and I haven’t received a return letter either. I understand you are very busy and

you are not going to return a lot of letters, but I would hope you

deal with us because we need the information from you to represent our constituents; that you have somebody on your staff highlight the fact and get back to us on the information that we need,

especially before a hearing.

Now, with respect to that, my main concern is that we might acquire through manufacture all the vaccines we need. Hopefully we

will have a system that will be able to do that, but there are some

issues about that also. But I am concerned about the issue of

whether or not we have the devices in place for needles and injections and whether there is a plan dealing with that. And I would

hope that you can answer that question.

I also believe the Federal Government needs a strategic vaccine

reserve and production capability. This would be a plant that in

times of emergency can be converted or switched on to meet vaccine needs. If the government cannot do this, we need to give business the incentive to have a facility that in times of need can push

out large numbers of needed vaccines and needles. Thank you.

Chairman TOM DAVIS. Thank you very much.

Mr. Lynch.

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Mr. LYNCH. Thank you, Mr. Chairman and Ranking Member

Waxman, for holding this hearing. I want to thank the Secretary

and members of the panel for helping the committee with its work.

I associate myself with the remarks of my colleagues here on

both sides of the aisle. I just have two areas that haven’t necessarily been addressed yet. One is, you know, we heard from Secretary Chertoff about the issue of rail security, and he said basically that the States are going to have to handle that responsibility, which I was surprised at, because an interstate rail security

system cannot be handled by individual States.

Then we heard from Mr. Michael Brown, who said that disaster

relief such as Katrina, the Katrina situation, that also should be

better handled by the States, even though that would have affected

multiple States, and I don’t think it could effectively be dealt with

in that fashion. And I noticed in the President’s plan which has recently come out, that federally we are going to handle 44 million

courses of this vaccine, and then the other, the balance of it, which

would be in the area of $500 million would be handled by individual States.

And I am just curious, with this trend of giving all this added

responsibility to the States, especially a global pandemic, asking individual States, in individual cases and circumstances, to handle

the responsibility of containing a global pandemic, I just—you

know, it is just a pattern of conduct that we have seen from this

administration of handing more and more responsibility to the

States for problems that they are not equipped to deal with. So I

am very concerned about that.

The second issue that has not been talked about, understandably, is an issue that has been brought up by the Association for

the Prudent Use of Antibiotics. Now, I realize it is a different animal than what we are dealing with from this avian flu, but also

they are concerned about the lack of incentives for drug companies

to develop new antibiotics and the lack of investment in government incentives for those drug companies to do so. And I am hoping that at some point in your remarks you might be able to address that concern. It is a problem of a different nature, but it is

quite similar to the growing problem that we have here with these

new iterations of flu, influenza epidemics that we are concerned

about at this hearing. So I look forward to your comments. Thank

you.

Chairman TOM DAVIS. Yes, sir. The gentleman from Maryland.

Mr. CUMMINGS. Thank you very much, Mr. Chairman, and again

I want to thank you and the ranking member for holding this hearing.

And I want to thank you, Mr. Secretary, and all of you, for being

with us this morning.

In the wake of any catastrophe, our citizens expect assurance

that our Government works hard to avert such a calamity and that

it is well prepared to meet their essential needs. Regrettably, recent events have shaken the American people’s faith in that certainty. The devastating flu vaccine shortage that typified last flu

season coupled with the failed response to Hurricane Katrina demonstrated that there is much work to be done to improve our Nation’s capacity to address an act of nature. If these lessons of our

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past are to have any value, we must seriously question our Nation’s pandemic influenza preparedness. Further, we must acknowledge that while we do not have control over nature, we do have

control over the policy choices that determine our ability to lessen

the impact of nature’s mighty blows.

Simply put, planning and execution matter. It is estimated that

a pandemic would result in the deaths of over 500,000 Americans,

and, in fact, 25 percent of the world’s population. The Baltimore

Sun reported in an article entitled Fears of Flu Pandemic Spurring

Preparations that 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.

One need not be an expert to comprehend the magnitude of such

a loss of life and the disastrous impact a pandemic would have on

our economy and our society. With this in mind, the time is long

overdue for the government to move forward in the best interests

of the Nation to ensure that a flu—a future flu pandemic is handled effectively.

Fulfilling this obligation demands a comprehensive plan, one

that covers intergovernmental coordination, international surveillance, public health and veterinary infrastructure, and process for

obtaining and distributing vaccines and antivirals.

The administration took a step in the right direction when it released a national strategy for pandemic influenza. The President

wisely stated, ‘‘in the last century our country and the world have

been hit by three influenza pandemics, and viruses from birds contributed to all of them.’’ Yet the same administration waited until

November 2005 to introduce a pandemic flu preparedness plan.

Americans should ask whether a flu pandemic was foreseeable during this long delay. The short answer is yes. It is unfortunate that

valuable time was wasted that should have been spent substantially preparing.

Although State and local health departments will function on the

front lines of the flu pandemic, the administration proposed undermining State and local preparedness by cutting $130 million in

Federal support of those efforts in fiscal year 2006. The President’s

strategy proposes that State and local health departments primarily would respond to a pandemic, but too many Americans’ assurances that localities are up to the task will not outweigh the

memory of thousands enduring long lines and lotteries, public confusion and the inequitable distribution of limited vaccines that

typified last year’s flu season. I fear these concerns may be well

founded.

Finally, I am also concerned that this plan creates an untenable

financial burden for some cash-strapped States and seeks to fund

State and local preparedness on the cheap. Specifically, the recently released strategy calls for only over $100 million to update

State pandemic plans, but also requires States to spend approximately $510 million to purchase antivirals. The Federal Government must spare no expense and exhaust every effort to ensure

that no citizen is given less of an opportunity to survive a pandemic because they reside in a poor State.

Mr. Chairman, the American people are closely watching how its

Government responds to this challenge, one that will no doubt test

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the wisdom of our priorities and the firmness of our resolve to protect our citizens from threats, both seen and unseen. In the end,

we will be judged not by the hearings that were held, nor by the

proposals that were offered, but by how well we tangibly lessened

human suffering and equipped our citizens with the ability to withstand the onslaught of a flu pandemic.

With that, I yield back and thank you.

[The prepared statement of Hon. Elijah E. Cummings follows:]

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Chairman TOM DAVIS. Thank you.

Mr. Secretary, thank you very much for your patience. We have

a vote on now; there is only one vote. Mr. Shays has already voted

and come back and prepared to keep the helm of this. But what

I want to do right now is let Mr. Cannon introduce you formally

to the committee. I have asked him to do that, being from your

home State. Then we will swear you in. And I will ask you at that

point if you want to take a break for 10 minutes and let Members

come back, or if you want to continue with your statement with Mr.

Shays presiding.

Chris, why don’t you go ahead.

Mr. CANNON. Thank you, Mr. Chairman. I couldn’t be more

proud to introduce my Governor, almost exactly my age. I think I

endorsed him before he ran for Governor the first time. He did a

great job. He was a three-term Governor of Utah. Then to my consternation he took one of the toughest jobs you can possibly take

in American Government, and that is to head up the EPA. He did

an impossible job remarkably well. And he has now taken on the

position of Secretary of HHS, which comes with more problems

than EPA, I suspect, a much more difficult task, much more difficult budget to deal with, and the focus of some of our problems

in America. And yet it also is one of the agencies that has the most

opportunities, and I am actually thrilled that he is there because

he has a great deal of history.

I was on an airplane recently with a mutual friend, Steve Prescott, who ran our Huntsman Cancer Center in Utah. He is one of

the guys who designed some of the breakthroughs we have had in

Utah, including a merger between the university hospital system

and our largest hospital, private hospital, Intermountain Health

Care, for the purpose of figuring out how we can better combat cancer. And Governor Leavitt then had worked with him to help set

up a not-for-profit, which I think is going to be transformational in

the way we do medicine in the very near future. He oversees, of

course, the CDC, National Cancer Institute and the FDA. Mr.

Souder’s subcommittee had a hearing with three of those agencies

represented. All three of them pointed out that the declining costs

of DNA decoding and the declining cost of computerization is transformational to our medical system.

I cannot imagine anyone better able to manage that process than

Secretary Leavitt, who has done some remarkable things, including

establishing the goal of getting a data base of health care so that

we can deal in a new context with the development of drugs or the

treating of disease through massive computing and databasing statistics rather than the double-blind study.

So it is my great honor to introduce my Governor, now the Secretary of HHS, Mike Leavitt. Thank you.

[The prepared statement of Hon. Chris Cannon follows:]

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Mr. LEAVITT. Thank you.

Chairman TOM DAVIS. Mr. Secretary, we always swear everyone

in before you testify, so just rise and raise your right hand, and

your staff.

For the record, we have Dr. Bruce Gellin, Dr. Anthony Fauci, Dr.

Julie Gerberding and Dr. William Raub here as well.

[Witnesses sworn.]

[Recess.]

Chairman TOM DAVIS. Mr. Secretary, thank you for your patience, and we will go ahead and proceed.

STATEMENT OF MICHAEL O. LEAVITT, SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES, ACCOMPANIED

BY DR. ANTHONY S. FAUCI, DIRECTOR, NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES, NATIONAL

INSTITUTES OF HEALTH, DEPARTMENT OF HEALTH AND

HUMAN SERVICES; DR. BRUCE GELLIN, DIRECTOR, NATIONAL VACCINE PLANNING OFFICE, DEPARTMENT OF

HEALTH AND HUMAN SERVICES; DR. JULIE GERBERDING,

DIRECTOR, CENTERS FOR DISEASE CONTROL AND PREVENTION, DEPARTMENT OF HEALTH AND HUMAN SERVICES;

AND DR. WILLIAM RAUB, SCIENCE ADVISOR TO THE SECRETARY, DEPARTMENT OF HEALTH AND HUMAN SERVICES

Secretary LEAVITT. Thank you, Mr. Chairman. This is a topic of

importance, I think, demonstrated by the number of members who

have expressed interest, and I look forward to the period where we

can interact directly.

Chairman TOM DAVIS. Let me note that your entire statement is

in the record, so you don’t have to——

Secretary LEAVITT. I would like to just summarize the statement

that was submitted.

The bottom line is that pandemics happen. And 10 times in the

last 300 years, 3 times in the last 100 years, we have had circumstances where literally, masses have been made ill and millions

have been caused to die. Whenever there is a human to human

transmission of a killer virus, it presents risk everywhere.

Currently, we’re worried about the HFN1 virus. It is primarily

an animal disease, but there is no certainty it will remain such.

There are troubling signs. If the H5N1 virus is not the spark of a

pandemic, there will ultimately be another. Pandemics happen,

they have happened in the past, they will happen in the future.

Yesterday, the President laid out a broad national strategy, it

calls on Congress to appropriate $7.1 billion. Today, I would like

to just provide an overview of that plan and then go directly to

questions.

I will lay the plan out in basically six parts. The first part is the

international surveillance; this was mentioned in the opening

statements. The importance of determining when the virus transitions to human to human, and where.

One can think of the world as a vast forest susceptible to fire.

Whenever a forest fire starts it starts with a spark. If you were

there when the spark happens, it can be—the damage can be limited quickly by simply putting it out. But if it’s allowed to smolder,

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or if it goes on for a period of time, it burns to the point that it

cannot be contained.

The construct of international surveillance involves having laboratories throughout the world, having epidemic investigators who

can be there when the spark happens, having rapid response

teams, having American expertise on the ground in all of the theaters where it is most likely to occur. It also involves joint containment agreements with our friends around the world to be there

jointly to bring our resources if it is possible to contain an outbreak.

The second portion of the plan I’ll refer to is domestic surveillance, essentially having the same capability in the United States

as we’ve spoken of around the world, knowing when it happens and

how broadly it has gone beyond, or if it’s gone beyond containment.

Again, it requires laboratories, it requires trained medical personnel. The plan calls for the development of a system known as

BioSense, which is already under development because of our interest in bioterrorism, where we would have real-time data available

both at the CDC, and also among local and State health departments, for the purpose of ascertaining when these things occur.

The third part of the plan that I will refer to, and what I believe

to be the foundation of this plan, is vaccines. The good news is that

we do have a vaccine that has produced a sufficient immune response to protect human beings, the bad new is we do not have the

capacity as a Nation within our vaccine industry to manufacture a

sufficient supply in timeframes that would protect the American

people, that needs to change. The plan calls for us to make heavy

investments in three basic areas. The first is the expanding of our

traditional egg base production of vaccine; the second is the rapid

development of cell-based technology; and the third is agivent technology so that we’re able to use that with the maximum level of

efficiency.

The plan calls for essentially two objectives to be met, the first

is to have the capacity of manufacturing 300 million courses of an

appropriate vaccine within a 6-month period of a strain being identified. The second objective is to have a stockpile of some 20 million

doses—or rather courses of vaccine for the purpose of being able to

provide early protection to first responders and so forth. We know

that vaccine would not likely be perfect because it would be the last

available vaccine, but it would at least give us some protection in

those early periods.

The forth area is in anti-virals. The importance of anti-virals is

evident, however, it should not be overstated. There are serious

limits in what anti-virals can do; they do need to be part of a comprehensive plan. Those on the panel today, if Members are interested, I’m sure we will be able to detail those limits. We are proposing collective stockpiles of some 81 million courses. The plan

calls for the Federal Government to pay for some 70 percent of

those and to provide States with the option of being able to acquire

more; it does not make mandatory their participation.

The fifth area is communication, informing the public with the

best available information. I think it’s been evident by the nature

of the conversation today by members of the committee, some are

worried about whether or not this is overreaction, others worry

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that we may have responded too slowly. Our objective now, and I

must say, I believe good leadership, is to speak in a way that informs but does not inflame, to inspire preparation, but not panic.

The last section—and I suspect we will have some conversation

about this—is the importance of State and local participation. And

Mr. Chairman, I would emphasize the unique nature of a pandemic

as a disaster. We have gone through many disasters in this country

just in the last several months. Katrina, for example, a terrible disaster, stretched over Louisiana, Mississippi and parts of Alabama.

It was, however, constrained to those areas. It was—the emergency

unfolded in a 2 or 3-day period. It has taken us, of course, longer,

and will take us longer to respond and to recover, but nevertheless

the damage was done in a very limited period of time. A pandemic,

on the other hand, is different, it is not constrained to a geographic

area. It likely would be unfolding in thousands of different locations across the country and across the world simultaneously.

It also is not constrained as to time. It won’t happen in a week,

it will happen in a year or more, and it will happen in waives, and

it will require that there are individual decisions made in different

communities across the country at different times and for different

reasons. What is happening in a rural city in Kansas will be different than what is happening in a metropolitan area in Tennessee.

And there will be as many iterations of the disaster as there are

locations.

The budget is presented in two major accounts, the vaccines and

anti-virals in one account, and the public health efforts between

the various public health efforts, we’re talking about nearly $600

million.

I would just like to conclude my talking about the dilemma that’s

been presented today that will someday people look back and say

H5N1 did not become a pandemic, therefore we overreacted? Will

they say at some point in time, well, they were crying wolf? We do

not know whether H5N1 will be the spark that creates a pandemic,

but we do that know pandemics happen, they’ve happened in the

past, they will happen in the future. And this plan is not about

H5N1 alone, it is about general pandemic preparedness. And when

we have concluded or when we have implemented this plan, the

United States of America will be a better and safer place. We will

have cell-based technology, something that will ultimately save

millions of lives, a revolution in the way we conduct the business

of vaccines and the way we protect the public from disease.

We will have annual flu vaccine capacity that well exceeds what

we have today. A great deal of conversation has gone on in the

committee today about the on-going difficulties of the flu vaccine

dilemmas in our annual flu; that is because we lack capacity. This

can change that once and for all, it can take off the table the dilemma of annual flu and pandemic flu vaccines by resolving it with

new capacity and new technology.

This plan will create better prepared State and local governments. It will also provide an international surveillance system for

disease. And we’ll have the piece of mind of knowing we are prepared.

Cell-based technology, annual flu capacity, better State and local

government preparedness, an international network of surveillance,

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piece of mind of knowing we’re prepared, that’s what this plan is

about, and I feel confident in saying, when it is implemented, that

America will be a safer and healthier place.

[The prepared statement of Secretary Leavitt follows:]

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Chairman TOM DAVIS. Mr. Secretary, thank you very much. And

I think this is the most proactive—did anyone else want to say

anything? I think this is the most proactive that any administration has ever been on this in history.

And as we learned from Hurricane Katrina, sometimes an ounce

of prevention is worth a pound of cure. Should a pandemic develop

and we are not prepared, we’re talking about a hole in our economy

of perhaps trillions of dollars, people not being able to move out of

the country from their cities, international tourism industry and

everything else. Plus, what it would be to medical bills and hospitals and everything else.

Let me ask this; according to the pandemic plan, the Federal

Government requires States to pay for a substantial portion of the

anti-virals. If States are responsible for the purchase of anti-virals,

will the Federal Government help ensure that all of the States receive a lower nationally negotiated price?

Secretary LEAVITT. Yes, Mr. Chairman, we will. And that’s a significant benefit.

I want to emphasize that our belief is that a pandemic is unique

to all natural disasters for reasons I enumerated in my opening

statement. It is not possible, it is a certainty that if we have a pandemic condition, communities all over the country will be dealing

with it, and they need to be able to deal with it in their own and

unique ways. We have—public health is a local and a State responsibility for a reason, because they’re able to respond to local conditions.

Now the plan that’s been put forward does have the national government paying for essentially 70 percent of the anti-virals, but a

very important part of the way we would split this up in terms of

divisions of labor, you will note that $400 million of the $1.4 billion

that we have proposed for anti-virals goes into research for new

and better anti-virals.

Why? Because there is no certainty at all that Tamiflu will be

effective against H5N1, let alone whatever virus might ultimately

be the one that in fact creates the pandemic. Any sense that having

Tamiflu is synonymous with preparation or preparedness is wrong?

It is an important part of a comprehensive strategy, but it is not

synonymous with preparedness.

And so tying one’s plan so closely to one anti-viral that may or

may not be effective would be a mistake. And we are working with

the—we want to work with the States to make it certain they have

it as part of their plan, but it does not, in essence, create an overdependence on that as their only remedy.

Chairman TOM DAVIS. I didn’t realize Tamiflu may not be effective. In that case, how long will it take to develop another antiviral?

Secretary LEAVITT. I’ll ask Dr. Fauci to talk about both of those

subjects, the limited effectiveness potential——

Chairman TOM DAVIS. And if I could just, because we’re limited

on time, throw out with that that we’ve heard some talk about

Roche having the rights to Tamiflu and having a limited production

capacity and our ability to get that out; and now I’m hearing that

may not be an answer anyway.

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Of course, you would only use this until—the vaccine is the best

defense, but you would need this in the short period. So you can

talk about that.

Dr. FAUCI. Yes, Mr. Chairman. Thank you, Mr. Secretary.

Tamiflu, the data that we have on the effectiveness on Tamiflu

relates very heavily on and almost exclusively on the use of it in

seasonal flu. And it’s clear that in the standard seasonal flu, if you

give Tamiflu, you need to give it within the first 24 to 48 hours to

get an effect, and its main effect is to shave off about a day and

a half from the symptomatic period of a viral infection with influenza. For example, if you would have been sick for 6 days or 7

days, you’re sick for 41⁄2 or 5 days.

The ability of Tamiflu to have a major impact on the seriousness

of the infection that you would predict or project with a pandemic

flu is still very much unclear. We’re pushing the agenda with

Tamiflu for stockpiling because it right now currently is the best

that we have, but all of us, myself and Dr. Gerberding and others,

are clearly in in our caution that this is not something that is going

to be essentially the show stopper for a pandemic flu.

With regard to your second question, we have a robust program,

and part of the research component of the plan is to pursue other

mechanisms of suppression of the virus, other viral targets in addition to the new amenities, which is the target for Tamiflu and

Relenza, as well as one other, the M2 protein, which is the target

of Amantadine and Rimantadine. So we are pursuing, both by

screening existing products as well as by targeting anti-virals to

get a better drug than Tamiflu.

Chairman TOM DAVIS. Thank you very much. My time is up, Mr.

Waxman, 5 minutes.

Mr. WAXMAN. Thank you, Mr. Chairman. Mr. Secretary, thank

you, and all of your colleagues who have come with you today and

appearing before us. And I appreciate that the administration is

taking this matter seriously. We do not know if there is going to

be a pandemic, but I think it’s prudent for us to make plans.

All the plans in the world aren’t going to help, though, if we

don’t have on the ground in State and local governments the ability

to respond to any kind of epidemic because they’re on the front

lines of a crisis, and they’ve got to have adequate funding to implement the plans. So I want to pursue that issue with you.

The President’s budget called for $130 million cut to the grants

to the States for public health preparedness, that was part of the

budget that we received much earlier in the year. The administration hasn’t rescinded that call for the budget cut. I know that

money is being directed elsewhere, but it means it’s less money for

the States to deal with any kind of public health emergency. Now

we have this pandemic flu strategy, and that calls for $100 million

to go to the States for planning activities, so it’s $100—so now they

got $30 million left, because if you can cut $130 million, you have

$100 now added, but there is an obligation for the States to spend

money for part of the costs of the anti-viral medications, the

Tamiflu or whatever other anti-virals there might be, and that is

a requirement, an unfunded requirement or obligation to spend

$510 million for the purchase of the anti-virals.

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So the States and the local governments look at your overall proposals, they’re not very enthusiastic about that. They say they can’t

afford it. Governor Huckaby, Republican of Arkansas, said ‘‘They

expect us to pay 75 cents on the dollar for flu medicine; that’s going

to be a tough pill to swallow.’’

New York City Public Health Commissioner submitted testimony

this morning that the administration’s budget plan, ‘‘would seriously undermine our preparedness capabilities,’’ and Dr. Rex archer, president of the National Association of City and County

Health Officials, and director of Health for Kansas City, MO, said

‘‘you can’t take $130 million with the right hand, give us $100 million with the left hand, with strings attached by the way, and expect that is going to get us where we need to go.’’ How do you respond? It seems to me there is going to be a real problem for these

local governments.

Secretary LEAVITT. As you pointed out, the $130 million was

moved from one account to another. Preparedness dollars for States

have actually gone up considerably. We also have substantial

grants that have been offered to the States over the course of a 3-

year period of $5 billion that we’re still working with the States to

draw down that can be used for this.

But most of all, Mr. Waxman, I would like to reconcile the

Tamiflu. We have a national goal of 81 million courses in collective

stockpiles, the plan calls for 50 million of those courses to be purchased entirely by the Federal Government and for us to—and we

will likely place those in stockpiles in the States. As Dr. Fauci indicated to you, if we don’t get Tamiflu, or if Tamiflu is not placed

into the hands of people who are sick within 24 to 48 hours, it does

not do the good that it’s intended for, or that it’s manufactured for.

The point is, it’s distribution that ultimately defines victory, so

we intend to put those stockpiles very closely out into the States

where they can be deployed. That is 70 percent of the total. If

States choose to buy more, we’re prepared to assist in that. We are

helping them meet a responsibility that they have, paying for 70

percent of the Tamiflu that will be available.

Now, we are willing to talk about how we go about it, because

we want the States to be involved in the planning of this. If it is

just knowing that the national government somehow has a stockpile of Tamiflu, they’re not going to be involved in the distribution,

and that’s where we want them to be.

Mr. WAXMAN. Well, Dr. Gerberding, as the head of the Center for

Disease Control, you work very closely with the State agencies that

have to be on the front lines. If they can’t afford to come up with

the money for their share of the anti-virals and they’re complaining

about it, they’re saying they can’t deal with it, how is this Federal,

State, local relationship going to work if they’re complaining that

they can’t do their job and the Federal Government is only paying

part of the cost.

Dr. GERBERDING. The State and local health officials have a

tough job, and they’ve been working hard over the last few years

with the investments in preparedness that we’ve been making to

try to dig out of a hole that’s been very deep for many decades, as

you know.

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I think the conversation that I had with the leaders of the health

agencies yesterday would indicate to me that they’re aware that

they have a responsibility and a role to play, they are aware that

we can’t be successful if every component of the public health system doesn’t step in and do its part. And we just want to work together to figure out how we are going to make sure that we have

equitable coverage with Tamiflu.

This is a pretty good deal for the States to get the Federal Government to buy the drug at a discount. Our planning is——

Mr. WAXMAN. Well, the States don’t have really a choice in this

matter. The national plan is for 25 percent of the population to be

covered in the stock pool, that requires that the States must purchase, it’s not an option. So we’re having, in effect, an unfunded

mandate.

Secretary LEAVITT. It is an option. If they choose to, we will help

them pay for it. We are going to be putting up the 50 million doses

distributed in ways that meet the needs of the plan. So if a State

chose not to do it, they would still have Tamiflu in their State, it

wouldn’t be the extent to which some other States might want to

have it. But they need to step up and help with this, too. We need

to have everyone involved in this, not just the Federal Government.

Mr. WAXMAN. You’ve got to continue your conversations with

them because they’re complaining about it. Because my red light

is on, if the chairman will indulge me for a minute.

Because you’re here, Mr. Secretary, I know this is not the end

of this whole issue, it is just the beginning and we’re going to have

further conversations, but I want to express to you that I’ve been

disappointed in my ability to get information from the Department.

And I have a stack of letters that I’ve sent to the Department, and

I just don’t get responses to them. I think if we’re going to have

the dialog and efforts to work together, I want to impress upon you

that we’re all busy, but you do have a lot of people working under

you, you don’t have to personally answer each letter. I will like to

impress upon that you have heard from other Members who have

had the similar complaint, even on the Republican side, it is important and I’d like to make sure that we get responses. Thank you,

Mr. Chairman.

Chairman TOM DAVIS. Thank you, Mr. Waxman.

Mr. Shays.

Mr. SHAYS. Thank you. I’d also like to add to Mr. Waxman’s

point. As the administration asks for more power, I think they

need more legislative oversight, and it would be helpful to have

greater cooperation, not less cooperation from the administration.

And I also want to say as you’re surrounded by four very competent professionals, and I have high regard for HHS, I have high

regard for you, Mr. Secretary, and the people who work around

you. There is a black mark, in my judgment, with how the FDA

has handled plan B when the experts have said that this should

be available to prevent pregnancies and still not have this resolved,

and I hope that you will find a way to quickly resolve that issue.

I want to ask you if—first, I want to acknowledge I think this

is a huge problem, and we probably should have been addressing

it sooner rather than later, but thank goodness we’re addressing it

now. But now I’m going to sound like I’m contradicting myself beVerDate 11-MAY-2000 14:57 Apr 02, 2006 Jkt 000000 PO 00000 Frm 00070 Fmt 6633 Sfmt 6633 D:\DOCS\24820.TXT HGOVREF1 PsN: HGOVREF1
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cause I’m interested to know from our experts why—this isn’t 1918.

And for instance, we don’t have traps and dirty trenches, there

were secondary infections. We have antibiotics, I guess developed

in 1929, so that was one good thing that happened in 1929. Those

are the things that come to mind to me that are different. Maybe

your experts could tell us what some of the other things that are

different.

Secretary LEAVITT. I will ask Dr. Gerberding to lead, and then

call on others.

Dr. GERBERDING. Well, we live in a very small world today, it’s

actually much smaller than it was in 1918. If you remember SARS

where one physician went to a hotel, stayed on the same floor of

that hotel with a dozen people and overnight SARS went around

the world.

Mr. SHAYS. So that would argue that it’s even a potentially worse

environment.

Dr. GERBERDING. The connectivity and the connection between

people in remote areas of the world with our backyard is much

greater today than it was in 1918, and that’s what we’re worried

about.

Mr. SHAYS. Any other points, either that minimize or make it

more of a problem?

Dr. FAUCI. One of the potential misconceptions that we hear is

that now that we’re living in the era of antibiotics, that most of

what happened in 1918 was due to secondary infections. When you

actually go back and examine carefully the records of what we

know, how the course of illness occurred in many, not all, but

many, many, and perhaps most of the patients, it was highly likely

that it was not the antibiotic-sensitive bacteria, that if we had the

antibiotics, then we would have had a major, major impact on

1918. It’s more likely that the virulence of the virus that is inherent to the virus itself caused a significant amount of the morbidity

and the mortality, and that is something that doesn’t change very

much from 1918 to now.

Mr. SHAYS. So you’re raising a second point as to why it may be

more serious, not less?

Dr. FAUCI. Yes. In fact, not necessarily more serious, where it

counterbalances the argument that well, we have antibiotics now,

we’re OK.

Mr. SHAYS. Any other points?

Dr. GELLIN. I want to build on what Dr. Fauci said in that the

predicament we’re in now with a single class of anti-virals, the

Neuraminidase inhibitors reflect the misuse of anti-microbials.

We’re all too familiar with the misuse of antibiotics, particularly in

the agricultural industry. There is evidence that there has been

misuse of the older class of anti-virals in that industry in Asia has

led to their——

Mr. SHAYS. So therefore they won’t be as effective?

Dr. GELLIN. Oh, no. There are two classes of anti-virals for flu,

one of them is essentially off the table for the H5 virus, H5N1

virus, and likely because of the misuse of a similar molecule in animal feed in Asia.

Mr. SHAYS. I guess I wasn’t making myself clear. In other words,

they are useless.

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Dr. GELLIN. One class might be useless, we are left with one.

Secretary LEAVITT. Mr. Shays, I would also mention one other

item. In 1918, they had the biology in play where we had no

human immunity, we essentially have the same circumstance

today. We are now dealing with 1918 biology in a 21st century new

cycle. SARS is a fascinating model to look at when you’re looking

at the cultural economic and political disruption that comes from

a pandemic. There were 8,000 people who were infected with

SARS, that is, in pandemic terms, small. It completely disrupted

the Chinese economy. There were major airports all over the world

that were essentially vacant.

Part of the difficulty of a pandemic is of course the health impacts, but the economic cultural impacts that it creates are also

profound.

Mr. SHAYS. Let me just—since my red light will come on soon,

just put in a word for the World Health Organization. I think it

is underfunded, underutilized. I know we sent some of our best experts to participate, and that’s terrific, but I really believe that

World Health Organization should be playing a greater role, and

the United States should be helping to encourage that. Thank you.

Chairman TOM DAVIS. Thank you.

Mr. Lantos, 5 minutes.

Mr. LANTOS. Thank you, Mr. Chairman.

I’d like to ask you or any of your colleagues, Mr. Secretary, to

address a, the geographic issue which I raised in my opening comment, San Francisco, Los Angeles, Seattle probably will be the first

impacted area given air travel from Asia.

Second, I’d like to ask you to give us, as detailed as you are capable, a report of the dealings with Roche. What are the generic companies that are planning to undertake production? What is the

timetable? What are the arrangements? Because as several of us

have indicated, we must see to it that getting the product to our

potential patients is dramatically more important than historic corporation relationships between companies and their licensees.

And finally, I would be grateful if you could discuss what specific

plans you have to see to it that the potentially most vulnerable are

diagnosed and then are provided with medication on a priority

basis; because this has not always been the case, as you well know.

Secretary LEAVITT. I will ask Dr. Gerberding to deal with the

issue of locale.

Dr. GERBERDING. Mr. Lantos, I share your concern about our

quarantine stations, and we recognize what an important point of

entry the west coast is.

I visited the Los Angeles quarantine station at LAX on Sunday

so I could get a firsthand look at what steps are in place. And I’m

pleased to report to you that with the investments that Congress

has been making over the last 2 years, we’ve been able to make

some significant improvements there, as well as in San Francisco

and Seattle. Overall, we are going from eight quarantine stations

at airports in 2003, we will have 18 by the end of this year, and

we will have 25 by the end of 2006.

At SFO, we have a medical officer now which we didn’t always

have, we have a senior inspector, and we are planning for the possibility of an airplane with someone with suspected pandemic

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strain, how we would quarantine and isolate people until further

evaluation could be conducted. So it’s a very, very important part

of our containment program. The Secretary has worked this

through in our doctrine, and we will be happy to keep you up to

date as we make additional improvements in our border security.

Mr. LANTOS. I appreciate that.

Secretary LEAVITT. With respect to Roche, we have had on-going,

very direct conversations. They have given us assurance that we

will have sufficient supplies to meet our objectives——

Mr. LANTOS. What are those assurances?

Secretary LEAVITT. They have made representations that we will

be able to reach our 20 million first target by fourth quarter of

2006, and that they also made further representations that we

could get to our 81 million goal by the summer of 2007. And I

might add that——

Mr. LANTOS. When you say—excuse me for interrupting. When

you say representations, Mr. Secretary, were these oral commitments? Is there anything in writing? Is there anything you are prepared to share with the Congress and the American people? Or

were these just conversations with Roche?

Secretary LEAVITT. We have ongoing negotiations with them. We

are systemically making orders as we have appropriations to do so.

We have orders in that will take us well over 5 million courses.

As respects the intellectual property issue, they have given us

their assurance that, and not just the United States, but the world,

that intellectual property issues will not be the means of constricting the supply. Now I am not a chemist, Congressman, but I have

worked hard to understand the process that is undertaken to manufacture Tamiflu. And it is clear to me that this is a highly complex process that involves as many as five different manufacturing

processes, some of which involve quite dangerous explosive processes.

Now I don’t believe it will be intellectual property disputes that

in any way limit the capacity for manufacturing, it’s going to be the

logistics. And it’s my view that it’s going to be, anywhere in the

world, more than a year before we have additional manufacturers,

and maybe as many as 2 years. That is just my assessment, and

the——

Mr. LANTOS. Mr. Secretary, no one questions your good intentions, but what is at stake is the lives of potentially vast numbers

of American citizens. Is there anything beyond conversation that

you have with Roche? Are there any documents, any documents

that you are prepared to share with this committee?

Secretary LEAVITT. The documents are, in fact, limited to those

that I have outlined——

Mr. LANTOS. If the Chair would indulge me for a moment, this

is a rather important item.

Chairman TOM DAVIS. I’ll give him an opportunity to answer it.

Secretary LEAVITT. It is important, and you were not in the room

when I made another thing that is very important and I hope clear,

and that is that, in any sense that Tamiflu is synonymous with

preparedness is wrong——

Mr. LANTOS. We know that.

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Secretary LEAVITT. And we have proposed a $400 million appropriation to advance the development and the manufacture of advanced and improved anti-virals. We believe that Tamiflu is an important part of a comprehensive plan, but it should not be viewed

as synonymous with good preparation.

We are putting forward a strategy that includes vaccines, that

includes anti-virals, that includes surveillance, that includes good

communication, and State and local preparedness.

Now we intend that every State would have a stockpile of

Tamiflu, and that it could be deployed in a way that would be consistent with their needs, because if we can’t get Tamiflu or some

other suitable anti-viral into the hands of a sick person, it has done

them no good unless it’s there within 24 to 48 hours. So part of this

is distribution, not just having a stockpile.

Chairman TOM DAVIS. Mr. Secretary, I think, though, Mr. Lantos’ question is, are there any documents that you could share with

the committee that have transpired between yourselves and the

drug company at issue?

Secretary LEAVITT. The documents that I’m aware of are those

that would relate to the purchase or the intent to purchase the first

5 million doses that I’ve spoken of.

Mr. LANTOS. There are discussions between Roche and generic

drug manufacturers; is that correct?

Secretary LEAVITT. That is correct.

Mr. LANTOS. What can you tell us about those negotiations, and

can we see those document as they become available?

Secretary LEAVITT. I am not party to those conversations, nor do

I believe that anyone at HHS is. However, we have instructed and

agreed with Roche that the FDA will work directly with them to

facilitate the licensing of those arrangements.

Mr. LANTOS. May I just raise one more issue, Mr. Chairman, it

will take just a minute. Several of my colleagues properly dealt

with the budgetary ramifications of all of this. Have you given any

thought of requesting the President to have a White House conference of donors from the private sector? Exxon made $10 billion

in one quarter on these inflated petroleum prices. It is high time

that these multi-national corporations with windfall profits deal

with the health problems of the American people. Given the fiscal

policies of the administration—which I think have been abominable, we have to turn to the private sector. Are there any plans

of having a White House conference of funding the resources necessary so we won’t have to have a dialog as you did with Mr. Waxman as to what happens if the States can’t afford it?

Secretary LEAVITT. Congressman, the President has made clear

that he will be bringing State and local officials together to plan,

and that——

Mr. LANTOS. I’m talking about the private sector.

Secretary LEAVITT. I know of no plans to do what you have suggested.

Mr. LANTOS. What would be your idea of it——

Chairman TOM DAVIS. Mr. Gutknecht is recognized for 5 minutes.

Mr. GUTKNECHT. Thank you, Mr. Chairman. Benjamin Franklin

said ‘‘I know no lamp by which to see the future than that of the

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past.’’ Mr. Secretary, 4 years ago, this city, indeed this very building, was the subject of an anthrax attack. And I know that most

of this transpired before your watch, but I have to ask a few questions and submit for the record some other questions.

I have a copy of a Newsweek article that was posted on November 2nd talking about what the Department is doing relative to acquiring anthrax vaccines, and it’s pretty troubling. And apparently,

it is not just troubling to Members of the House, I also have a letter and an article—that I’d like to submit, Mr. Chairman, for the

record—from CQ.com, with a letter enclosed from Senator Grassley

asking about how we’re handling this anthrax vaccine contract, as

well as a letter that I’d like to submit from a former colleague of

the House, and now a Member of the Senate, Dr. Tom Coburn. And

in that letter, he raises 11 very specific questions.

[The information referred to follows:]

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Mr. GUTKNECHT. Now, Mr. Secretary, have you received that letter from Senator Coburn?

Secretary LEAVITT. I have personally not read the letter. I do not

know if it’s been received yet.

Mr. GUTKNECHT. Well, the reason I’m going to submit it here in

committee is that I hope you will not only respond to him, but I

hope you will respond to the questions from this committee, because I think it does raise serious questions about the ability of the

Department to manage these large contracts.

Four years after the anthrax problem we had here in the Capitol

building, we still can’t really say that we’re protected with adequate doses of anthrax vaccine. Now, I try to remind—and you’re

not the first one I have reminded this of, but we won World War

II in 31⁄2 years, OK, and it shouldn’t take 4 or 5 years for us to

ramp up production and to purchase of an adequate supply of anthrax vaccine. What is troubled that is raised in the Newsweek article is that a contract has been given to a company, an $877 million contract has been given to a company that has never passed—

I think they’ve never gone to phase three trials with this particular

vaccine. They have, and it’s documented at least in the article, that

they have serious financial problems and are not going to be able

to meet their production quotas this year, and perhaps not even

next year.

And I go back to my statement that if we’re unable to manage

an issue that has been around for 4 years, what gives us confidence

that we’re going to be able to manage the Avian Flu problem?

Secretary LEAVITT. Congressman, you’re referencing the fact that

we are moving to develop a better anthrax medication. I’d like to

ask Dr. Fauci to give you an update on our progress, and to make

clear that we do, in fact, or have, in fact, made substantial preparation for anthrax, we’re just working to get better all the time. So

Dr. Fauci.

Dr. FAUCI. Thank you, Mr. Secretary.

As you know, there are two anthrax vaccines, there is the AVA,

the standard one that have been used with the military. An Institute of Medicine committee has made it very clear that in order to

prepare the country for an anthrax attack, that we need to make

attempts to go beyond the older technology and use a new recombinant technology, which is the recombinant protective antigen. We

have a supply, a modest supply in the stockpile of the older AVA,

and there is an order for an additional amount of the AVA. But simultaneous with that, in the procurement process of getting companies to bid for making the recombinant protective antigen, the

comment that you made is correct, we did not, and at the time—

and this is an issue with trying to incentivize the big companies

to get involved, the fact that the company in question, Vasogen,

had not produced a vaccine beyond a phase 3 trial, I think bespeaks the lack of incentive of bigger companies to get involved, so

we had to go with companies that, in fact, don’t have a track record

like a Merck or a GlaxoSmithKline and others.

You’re correct that the pace of the milestones of the contract of

getting the material into the strategic national stockpile is, in fact,

slower than the Department had hoped it would be. This is being

monitored very carefully by the contract people, and we would be

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happy to keep you abreast of how this goes. But we are aware of

the fact that they’re behind schedule, and nonetheless, we will continue to monitor them very closely.

Mr. GUTKNECHT. Well, Mr. Secretary, thank you for that answer,

and it helps some, but I think ultimately the word that the American people are going to be using more and more about how we

spend their money is accountability. And if we’re going to give contracts to people and we expect them to live up to their end of that

contract, there have to be some consequences when they don’t. And

the consequence seems to be, around this city, well, gee whiz, you

didn’t meet that goal, we’ll give you more money, and I’m not sure

that’s going to cut it.

The other thing I will say, though, and perhaps the most important thing that’s come up out of this hearing so far this morning,

at least from my perspective, is to deflate the idea that Tamiflu is

the silver bullet relative to the potential outbreak of an Avian Flu

virus pandemic. I yield back the balance of my time.

Chairman TOM DAVIS. Thank you very much.

Mr. Kucinich.

Mr. KUCINICH. Thank you very much.

Mr. Secretary, you stated earlier the obvious, you’re not a chemist, but you are the Secretary. At what point are you going to act

on behalf of the American public and issue a compulsory license for

Tamiflu?

Secretary LEAVITT. Congressman, I mentioned earlier that there were—we’ve put $400 million into our proposal for the development

of new anti-viral drugs.

Mr. KUCINICH. Could you answer the question directly, Mr. Secretary? It was a simple question.

Secretary LEAVITT. I do not intend to, if that’s a direct answer.

Mr. KUCINICH. Mr. Chairman, that’s——

Chairman TOM DAVIS. That’s his answer. Do you have another

question?

Mr. KUCINICH. Are you invoking the fifth amendment?

Secretary LEAVITT. No. I don’t think I can be any more plain——

Mr. KUCINICH. You just said you don’t intend to—you don’t intend to what? You don’t intend to answer the question?

Chairman TOM DAVIS. He doesn’t intend to invoke it, I think it’s

pretty clear.

Mr. KUCINICH. You don’t intend to issue compulsory licenses?

Secretary LEAVITT. That is correct.

Mr. KUCINICH. Why not?

Secretary LEAVITT. Because it’s my belief that if we want to have

the last anti-viral or new product we will ever have in this country,

we will begin to violate intellectual property and patent rights——

Mr. KUCINICH. So you believe that intellectual property and patent rights are more important than having a large supply of an

anti-viral that could save lives?

Secretary LEAVITT. I do not believe that violating their patent

would unleash a new stream of Tamiflu.

Mr. KUCINICH. There are, according to some statements, over 100

companies waiting to begin production of Tamiflu. And contrary to

what you’ve said about the complex process, there are many people

waiting to go forward with the production. Now for you to sit here

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as Secretary of HHS, it’s kind of shocking to see you here defending intellectual property rights when the American people could be

facing the results of a pandemic.

I want to ask you a question here. Have you had cabinet meetings? Have there been cabinet meetings about this issue of antiviral and the Avian Flu?

Secretary LEAVITT. Yes.

Mr. KUCINICH. And have you participated in those meetings?

Secretary LEAVITT. I have.

Mr. KUCINICH. And has the Secretary of Defense participated in

those meetings?

Secretary LEAVITT. Yes.

Mr. KUCINICH. Are you aware that the Secretary of Defense is an

investor in Gilead Sciences, the California biotech company that

owns rights to Tamiflu?

Secretary LEAVITT. I’m aware from news accounts that he has

clearly set aside any interest in purchases of Tamiflu.

Mr. KUCINICH. You spoke to this being a highly complex process.

Have you talked to people at Gilead?

Secretary LEAVITT. Yes, I have.

Mr. KUCINICH. And have people at Gilead made you aware that

there are over 100 companies waiting to provide production of

Tamiflu?

Secretary LEAVITT. Congressman, that isn’t the case.

Mr. KUCINICH. Well, what is the case? Have they made you

aware that there are many companies waiting to manufacture

Tamiflu?

Secretary LEAVITT. They have made clear to me that there are

those that have expressed an interest in licensing the product. And

Roche has made clear to me that they are prepared——

Mr. KUCINICH. How many?

Secretary LEAVITT. They have not given me a number.

Mr. KUCINICH. And you’re the Secretary and you never asked for

a number when we’re looking at increasing the size of Tamiflu?

That’s incredible.

Secretary LEAVITT. Congressman, if I thought we had the capacity to unleash a needed anti-viral, or that in some fashion we

would be withholding an important life-saving drug, we would take

whatever action is necessary. However, I do not believe, nor do my

advisors nor would I say would the FDA believe that would occur.

Mr. KUCINICH. That what would occur?

Secretary LEAVITT. It is the chemical process, it is the manufacturing process that is constraining the capacity for this to be developed. Roche has made is very clear that they’re prepared to license

anyone who wants to manufacture it, but they’re going to have to

go through a very detailed process——

Mr. KUCINICH. Several countries have asked Roche for the right

to make the generic copies of Tamiflu. I have another question to

ask you. Are you negotiating a price with Roche for Tamiflu or are

they setting a price?

Secretary LEAVITT. We’re negotiating, Congressman.

Mr. KUCINICH. And when you’re negotiating, is it in the same

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panies to get the lowest possible price; or are you negotiating it so

they can make the most profit?

Secretary LEAVITT. We are negotiating a price that has been

steadily downward. They’ve been responding——

Mr. KUCINICH. Are you going to make those documents available

to this committee so we can make sure that the American taxpayers are not paying a premium for this drug?

Secretary LEAVITT. To the extent that’s necessary.

Mr. KUCINICH. Mr. Chairman, I think it would be important to

the committee to have that information because they already

talked about a first billion dollars for an anti-viral, since Tamiflu

is the most effective, it certainly appears to me that we ought to

know what we’re getting for our money.

I think that this committee, Mr. Chairman, has an obligation to

stay on this issue of compulsory licensing. For this administration

to be in a position of taking a stronger issue with support for intellectual property than they are for making a wide availability of

Tamiflu is pretty shocking and ought to send a message to the people of this country where this administration’s priorities lie.

Chairman TOM DAVIS. Thank you, Mr. Kucinich, I think that

question is addressed to me, and I think the answer is pretty clear

that if Tamiflu were the solution and we knew that was the solution, we could be out there doing all kinds of things, but we’re not

even sure that is going to be helpful in a pandemic, and there have

to be other anti-virals that have to be developed. And who is going

to spend the money developing an anti-viral if whatever money is

spent in the research and development is just taken away from

them and given to somebody else? I think that’s the way the markets work, and I think that, from my perspective, that the Secretary is behaving responsibly. And having said that, obviously

when the prices are negotiated, this committee has oversight responsibility, and we will be happy to work with the Secretary and

everyone else to do that.

Mr. KUCINICH. Will the gentleman yield?

Chairman TOM DAVIS. If you have another constructive comment,

I want to get——

Mr. KUCINICH. Well, I have a question. Are we saying that even

if Roche refused to make more Tamiflu or provide licenses to other

companies and thousands of Americans lives hang in the balance,

that we would still——

Chairman TOM DAVIS. No. And that’s not the case.

Secretary LEAVITT. Mr. Chairman, no one is making that suggestion.

Chairman TOM DAVIS. Of course not.

Secretary LEAVITT. This is a very complex chemical manufacturing process. And to simply say that there are hundreds out there

that are, a, willing, and b, able to manufacture it is a misstatement

of the truth and it is——

Mr. KUCINICH. Well, your drilling for oil is complex, too. We’re

seeing the American consumer getting hit two ways here.

Chairman TOM DAVIS. I think we are getting a little off.

Mr. KUCINICH. I yield back.

Chairman TOM DAVIS. Mr. Burton.

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Mr. BURTON. While we’re on a couple of other subjects here, I

do—when we passed Medicare prescription drug bill, one of the

things that I was concerned about was that we do negotiate prices,

the VA does, with the pharmaceutical companies, and there was a

prohibition against that in the Medicare prescription drug bill, and

I think that is something that ought to be revisited. Obviously, we

want the pharmaceutical industry to make a lot of money because

we want them to be able to do the research and development that

is necessary for new pharmaceutical products and drugs, but at the

same time, we ought to do what we can to make sure that there

is a negotiation process, like there are in other countries, as far as

buying these pharmaceuticals.

If we did that and provided a protection against the possible

counterfeiting of pharmaceuticals—and that can be done—I’ve got

a bill I’m going to introduce to do that—then I think we could negotiate these prices down like they’re doing in other places, and that

would be very good.

I read an article in the Wall Street Journal the other day from

some noted physicians and scientists, and it said that—and I think

it verifies what the chairman just said, and that is, that if we come

up with a vaccination against the avian flu, it might mutate into

something else and the vaccine might not be capable of dealing

with a mutation that takes place. So this is a revolving, revolving

situation that we face. And Tamiflu, while it might help now, if we

produce an awful lot of it, by the time we get to the point where

we do have an epidemic, it might not be worth the production costs

that we did. So this is something that has to be looked at on a continual basis, as I understand it; is that correct?

Secretary LEAVITT. Your point is correct. That’s one of the worries that the scientists at this table would express on Tamiflu. We

don’t know what the virus will be that will spark a pandemic. It’s

possible Tamiflu would have a positive impact, it is also quite possible it would not. And if we have simply used our resources to provide a stockpile of Tamiflu, we would not have prepared ourselves

adequately.

Mr. BURTON. And it is my understanding from—go ahead, Dr.

Fauci.

Dr. FAUCI. Mr. Burton, you raise an incredibly important question that is at the crux of what we’re doing. At the same time that

we’re stockpiling, to the best that we can, Tamiflu, we’re investing

in alternative anti-viral drugs in case we run out of options with

the evolution of resistance. Or even if in its best form, Tamiflu

might not be up to the task of stopping this because of what I had

mentioned in an earlier question, that we have no guarantee that

this is going to be highly effective.

With regard to the vaccine, you bring up an even more important

point, and it’s the two-pronged approach of vaccine in the Department’s plan, and that is at the same time that we’re actually building a stockpile of the vaccine that we have in hand at this time,

we are building the capacity to be able to respond in a timely and

expeditious manner if and when—and we hope it never happens—

but if and when the vaccine—the virus changes enough that we

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sion of the virus that we’re dealing with. So we’re doing them at

the same time.

Mr. BURTON. And in the event, as I understand it from our testimony and answering other questions, in the event that it looks like

there is going to be a production problem as the epidemic or pandemic grows, you would be willing to do emergency licensing with

other pharmaceutical companies, even generics, in order to get the

production level up to where it should be as quickly as possible.

Secretary LEAVITT. We would do what we need to do to provide

for preparation for a pandemic.

Mr. BURTON. But you’re prepared to do that if you have to do it.

Secretary LEAVITT. We will do what we have to do to protect the

American people.

Mr. BURTON. Well, I really would like to know. I mean, in the

event, let’s say that Roche or any pharmaceutical company that

makes vaccines is not capable of production levels that will protect

as many Americans and people as possible, you would do whatever

it took——

Secretary LEAVITT. We will do whatever it takes to protect the

American people.

Mr. BURTON. That’s what I wanted to hear, that’s what you

wanted to hear.

And finally, let me just go back to something I said in my opening statement. It is extremely important, in my opinion, and I’ve

talked to you about this before, that we get mercury out of vaccines, adult as well as children vaccines, and you can do that, and

you know you can, it might cost a little bit more. And I want to

give the pharmaceutical industry the protection it wants against

class action lawsuits, I’m for tort reform.

But the only way that many of us in good conscience can do that,

and I think you might run into a problem here, and we’re going to

be watching the legislation that goes through to deal with this, is

that we have to make sure that the Vaccine Injury Compensation

Fund is user friendly so that people who do have children that are

damaged or adults that are damaged have access to that and they

don’t have to go through a 10 or 12-year process to get compensation for the damage that’s been done.

So if we could get the mercury out of the vaccines and go to single shop vials as necessary, make sure the Vaccine Injury Compensation Fund is user friendly, then you’re going to get, and the

vaccine industry is going to get what they want, and that is, protection against class action lawsuits.

We tried to do that in the 1980’s. I and others are willing to do

that now, we just want to make sure that the people who are damaged do have a modicum of protection, and right now that doesn’t

appear to be the case. Mr. Chairman.

Chairman TOM DAVIS. Thank you very much.

Ms. Norton.

Ms. NORTON. Thank you, Mr. Chairman.

Mr. Secretary, I have questions on this issue, but I think I

should give you the opportunity to respond to the glitches we’ve

seen in the distribution system, to indicate where they come from

and to give any assurances that you can about the existing flu vaccine. I think the overreaction problem comes from the fact that if

87

people see this one and are not assured, then of course, they’re not

going to take very seriously what we’re trying, and what you quite

appropriately are trying to focus them on.

Can you just give us some word about the issues that have come

up, besides the fact that we know large numbers of people are coming forward?

Secretary LEAVITT. I’ll ask Dr. Gerberding to give you an update.

Ms. NORTON. I’m sorry?

Secretary LEAVITT. I will ask Dr. Gerberding from CDC to give

you an update.

Dr. GERBERDING. Thank you. Where we are right now this year

with the vaccine supply is that approximately 63 million doses of

vaccine have already been distributed. We’re expecting more than

80 million doses to be available this year, which is potentially more

than we’ve ever delivered in any given year——

Ms. NORTON. I think I want to get on to my questions here. I

simply want to know, because we know of the availability, I’m trying to find out about the distribution glitches, in particular, because otherwise I won’t get to ask my other questions.

Dr. GERBERDING. The distribution is in the hands of the private

sector, as is most of the vaccines.

Ms. NORTON. So there is nothing the CDC can do about it?

Dr. GERBERDING. It is not something that we have control over.

That’s been one of the challenges and why what the President is

proposing is so helpful to us because we can really increase our

seasonal flu vaccine supply——

Ms. NORTON. I’m very sorry to hear that. It has a direct effect

upon people who will have any confidence on what you’re doing on

the pandemic. And I ask you to look into the matter of distribution

and not simply throw your hands up and say I guess there’s nothing we can do about that.

If you can’t get it to us, and I repeat what—I wrote it down, Mr.

Secretary, distribution defines victory. Well, let me tell you, thousands of people die in the United States every year despite the fact

that we do have vaccine available, so if you can’t get it to them,

if you can’t help us on that score, then I guess victory is not ours.

Secretary LEAVITT. Ms. Norton, at the break I made a call, because of your opening statement I wanted to make certain I had

the facts. There are two components to distribution, one is the ability for the company to get it to the place where it’s been ordered,

the other is the need for them to order enough. Washington, DC,

ordered only 33,000 doses or, rather, courses of the vaccine, and

one of the reasons that they may be having a shortage is because

they didn’t order enough.

Ms. NORTON. So you’re saying—and so the fact that Walgreens

across the country says they’re not going to do it anymore——

Secretary, LEAVITT. There are distribution challenges, but in

some cases, communities also didn’t order enough.

Ms. NORTON. I will check with our Department of Health, and

I’m sure the Congressman will check with his, and I appreciate

that answer.

We’ve had trials that help us the next time to do know what do.

The trial in this case was the smallpox vaccine, this completely collapsed. The President made a big and important announcement.

88

Most experts believe that the reason was that, while the manufacturer got a liability shield, people, first responders, that’s who we’re

trying to get to go first, didn’t have any confidence that if, in fact,

something happened, that there would be some kind of compensation for them.

Now you know, Mr. Secretary, this—we get parents to vaccinate

children because of the Vaccine Injury Compensation Program for

childhood vaccines. The President didn’t even mention this, even

though he’s had one failure already. You would think that there

would have been some mention of or acknowledgement of that failure and saying that they were going to take some steps to deal

with it.

Let me ask you whether you believe, at least in principle, that

first responders who might also be asked to take this vaccine first

deserve to be—and in light of our experience—to be effective must

be assured that there will be some kind of compensation in case

some small number, I’m sure it will be small, are, in fact, injured

from the vaccine.

Secretary LEAVITT. We do need to provide incentives for first responders to be inoculated. We will need them very much in a State

of national emergency, whether it’s smallpox or a pandemic.

Ms. NORTON. And you think the childhood vaccines compensation

program is something of a model that we might follow here?

Secretary LEAVITT. I know that has been effective to a degree

and it can be improved still. I expect as the discussion goes forward

it will be discussed.

Ms. NORTON. Well, it will be on you, Mr. Chairman, if you put

it out to first responders and you get the same response you got

from smallpox, so be forewarned.

Final question. Dr. Fauci testified here about—gave us some real

hope during the last crisis—about moving on from this egg-based

manufacturing to state-of-the-art, or the art apparently isn’t here,

cell culture, and, one, do we even have—are we any closer even for

our annual vaccine needs; and two, is there any hope that, moving

forward, we can leave this slow way of dealing with manufacturing

of these vaccines for the annual flus and the other pandemics.

Dr. FAUCI. Yes. Thank you, Ms. Norton. The process that is going

on now, since the last time I have spoken to you there has been

considerably more of a transition. Right now the current technology

of the industry as a whole is egg-based. The future of the influenza

vaccine production will be based on cell. We are making significant

investments, as are the companies themselves on their own dime,

to ultimately transition into cell-based. Depending on the company,

some are well into doing the transition——

Ms. NORTON. Any waiting on the annual vaccines, on cell-based

on how close are they——

Dr. FAUCI. The annual vaccine for the seasonal flu that we will

be distributing to our citizens at least over the next couple of years

will continue to be egg——

Ms. NORTON. How soon, Dr. Fauci, even on that?

Dr. FAUCI. The industry likely will not transition over to a full

cell-based for at least 4 years or more. I want to just emphasize,

Ms. Norton, that this advantage, the primary advantage of cellbased is what we call surge capacity, the ability to rapidly rev up

89

on more doses and to have the flexibility of changing in midstream

on the numbers that you need. We appreciate that is the wave of

the future, but the technology itself will not allow the industry as

a whole to get there for the next few years. So this year’s is certainly egg-based. And I can guarantee you that next year is going

to be egg-based also.

Chairman TOM DAVIS. Thank you. Thank you for that explanation.

Mr. Cannon.

Mr. CANNON. Thank you, Mr. Chairman.

I chair the Subcommittee on Commercial and Administrative

Law which is part of the Judiciary Committee, and we are going

to have a hearing next week on a tort liability limitation for flu

vaccination or manufacturers of flu vaccine. And that is Darrell

Issa’s bill. So I got a bit engaged in this.

And if I can followup on the question of the gentlelady from D.C.

In some of our recent discussions, it sounds to me like industry has

had huge failures, huge costs, and not much progress on cell-based

vaccines. And I was just as recently as yesterday told that—by a

major manufacturer—that this is at least 5 years off. And that is

‘‘at least.’’ So you said not within 4 years, but that means in 5

years or beyond we are looking at it. So this is not imminent; isn’t

that the case?

Dr. FAUCI. That is the case. It is not imminent. I think the investment that is taking place within the budget associated with the

plan that was just released, that could be accelerated somewhat.

But it is talking about 4 years at least and probably 5.

Mr. CANNON. We had—I think this is the same science-based

issue, but on line Newsweek this week has an Isikoff story so this

is a very high-level story that they are pursuing. I take it from

your response that you are familiar with that Dr. Fauci?

Dr. FAUCI. Uh-huh.

Mr. CANNON. It is talking about the anthrax vaccine and VaxGen that is producing that with like a $900 million $800-some-odd, almost $900 million in funding, and only one company bid on the

project. And the other companies refused to bid because it was not

feasible to do it in the timeframes that the RFP suggested, and so

now we have a small company failing to perform in an area where

we—this is not—not bird flu, but it is associated because we are

talking about the same technology here where we have an experimental technology to deal with a disease that we have already been

attacked with, it has already been a bioterrorist tool, attacked several times with, and yet we don’t have a stockpile, even though my

understanding is that we have a company that has an FDA-approved vaccine for anthrax.

Is that a fair statement of where we are?

Dr. FAUCI. Yes, it is a fair statement. A little bit of a different

interpretation of it, because there is a history behind why a company is pursuing what you say is an experimental approach. Which

is not necessarily experimental; it is a recombinant DNA technology that is used with other vaccines. The Institute of Medicine,

after careful examination of the anthrax problem, recommended

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binant DNA technology, the RPA. The vaccine that you refer to

that is already licensed is the AVA that has been used in our

Armed Forces. We do have some of that in our stockpile, and we

have actually recently put in a purchase for an additional amount

of the older AVA vaccine. The recombinant protective antigen is by

a company that you mentioned, VaxGen. It is one of the few companies that put in a bid for the simple reason that we have trouble

incentivizing the large companies to even get involved in the vaccine production industry.

Mr. CANNON. And I think in part that is because of what Mr.

Burton said about liability. We want to help solve some of these liability problems. But are we going to be in the business of paying

Federal dollars to develop marginal technologies with companies—

and by the way, I think it was in the article someone mentioned

that these guys are being sued because they overstated what they

could do with an AIDS vaccine that didn’t work.

So what you really have here, at least to me, sounds like a mar- ginal company that is willing to say, yeah, we will do that $877

million, whatever that number is.

We are at the table and then we get the problems because I believe, as I understand it, that the other companies were saying we

can’t do what you are tasking us to do. And so are we just spending

Federal money to create, with a hope and a lot of dollars, a path

to something that may be good in the long run but which we can

get to reasonably?

Dr. FAUCI. I think it is important to put into context that the ultimate purchase of RPA or any other of the countermeasures that

will go into the Strategic National Stockpile will be through a

mechanism called BioShield which is money that does not go to the

company except if they deliver the product. So, although we will be

late, they will not get paid for a product that does not get delivered.

Mr. CANNON. But of the $800 or $900 million we are dealing here

for VaxGen, how much of that are they getting in advance to cover

their R&D and other expenses?

Dr. FAUCI. They will get according to what the milestone is. So

they will get the money when they meet a milestone. So if their

milestone is late, their money will be late. If they never reach the

milestone, they will not get the money.

Mr. CANNON. I would just as soon see this not become a major

issue, but let me jump on because I think there are other issues

that are more important. In the hearing I chaired recently in Mr.

Souder’s subcommittee—I mentioned in this my introduction of the

Governor, and now Mr. Secretary—that there is an absolute consensus that the decreasing cost of DNA decoding and decreasing

cost of computing has transformed the industry.

And I know Secretary Leavitt has been deeply involved in these

kinds of issues. But there are at least a couple, maybe three different new technologies out there which allow immediate decoding

not in a half hour, much later in time, but immediate decoding of

DNA, which should allow us to be much more proactive in identifying where we are having these outbreaks.

Is anybody looking at that kind of technology in the Department

today, and does it hold promise?

91

Mr. LEAVITT. The answer is yes. There is one point that I think

Dr. Raub could add to this question that might be helpful. Could

he have a moment.

Chairman TOM DAVIS. Sure. Dr. Raub, please respond and then

we will move to Mr. Van Hollen.

Mr. RAUB. You were citing the article, and I have not seen that

particular one, but it is incorrect to say that the VaxGen was the

only bidder. In fact, we had multiple bidders. We had a spirited

competition. It’s true, the large industries stayed on the sidelines

for its own reasons. But we had strong proposals, a very thorough

technical review, and VaxGen won that competition.

Mr. CANNON. I hope, Mr. Chairman, that the Secretary could address the issue of new technology and identifying the DNA strands

that identify the flu so that we can get a—if that would—the question, I guess, would that provide a better tool for identifying and

containing a pandemic? And is it something we are pursuing?

Secretary LEAVITT. I will ask Dr. Gerberding. She can give you

what I think will be a more satisfying answer.

Dr. GERBERDING. I think what you’re referring to is the use of

DNA-based diagnostics. In other words, to detect not the whole

virus or wait until we grow it up and culture it, but to probe for

specific components of the virus. And that technology is well underway. Actually, some preliminary approaches to this, using chip

technology, are in clinical study now.

Mr. CANNON. If the chairman would grant unanimous consent for

10 more seconds.

Mr. BURTON [presiding]. If Mr. Van Hollen doesn’t mind.

Mr. CANNON. Let me just suggest that I’ve heard of a test on malaria at Johns Hopkins using a new device that has been radically

successful. And it might be worth pursuing that from your point of

view. And I would be happy to get you information if you would

like.

Mr. BURTON. Mr. Van Hollen.

Mr. VAN HOLLEN. Thank you, Mr. Chairman. And, again, thank

all of you for your testimony.

Mr. Secretary, I want to focus on some of the issues I raised in

my opening comments regarding the fact that as I look at the plan,

I don’t think enough emphasis is being spent on that early warning/early intervention/prevention part it.

As I listened to the testimony of a lot of people from the World

Health Organization, the FAO and others, they say a critical part

of a plan to prevent an outbreak would be to try to find a way to

stop or slow down the transmission of the disease through the carriers, avian flu, birds and others.

And my question No. 1 is, first, do you agree that that is an important part of the strategy? No. 2, what are your understandings

of the cost and what it would take in terms of resources to address

that strategy? And No. 3, what amount of money in this plan—I

don’t see any money especially for that particular part, transmission among the carriers—is in this plan, and how do we make

up any gap in that funding?

Secretary LEAVITT. I spent 9 days in Southeast Asia with the

head of the World Health Organization and the head of the animal

health organizations and with the pandemic representative from

92

the U.N. We spent time in the five major countries where the most

cases have manifest.

I had a chance to walk through wet markets and go to farms and

to sit down and speak with people who had actually contracted

avian flu, and I think I began to develop a pretty good sense of

what the challenge is.

We are investing heavily already, and have been for some time,

in an international surveillance—disease surveillance system. We

have people on the ground. We have laboratories on the ground.

We are doing what we can now to build laboratory capacity. Ultimately we are going to have a decision to make when there is an

outbreak of a pandemic flu, whatever the designation.

Is the capacity to contain possible? If it is a small village in a

remote area of Thailand or Cambodia and it hasn’t gone beyond

that village, and it is a strain that appears to have low efficiency

and not much virulence, then it is quite possible that it would be

a very good use of our resources to go in and to put that spark out

while we can.

If it is in a metropolitan area and it has spread to a number of

places, and it is already achieving person-to-person transmission in

a highly efficient way, the use of limited resources in the United

States may not be the best choice.

Mr. VAN HOLLEN. Mr. Secretary, if I could, because my time is

short, if I could just—I understand the importance of trying to prevent the outbreak among—if it gets from human-to-human transmission and the importance of that.

What I was referring to was part of a strategy that I understand

many of the health experts in the WHO are talking about, trying

to slow the transmission among the carrier population now of birds.

You know, they have slaughtered millions of birds and we need to

keep doing that to the extent that the virus exhibits itself. But

there has been some talk about methods, through farming methods, but also even through putting stuff in the feed of chickens that

would sort of immunize them against the further spread. And since

they are the carriers, I don’t see anything in this plan with respect

to that.

Do you think that we—do you think that WHO and FAO folks

are right, that we should focus on that as part of our strategy? And

what resources will that take?

Secretary LEAVITT. The plan that—the President’s plan does, in

fact, have funds that would go to the Department of Agriculture

and others who will be participating in those efforts. However, we

need to remember that we now have a situation with tens of hundreds of millions of wild birds who are carrying the virus from continent to continent. We are seeing that unfold in the news virtually

every day.

I had a chance to see birds being culled and vaccinated and other

processes and, frankly, they are imperfect. And they are inconsistent. And while I believe everything that you have said is, in principle, an important step, I did not come away from Southeast Asia

with high optimism that is going to ultimately be the way in which

we defeat this problem.

Mr. VAN HOLLEN. And don’t get me wrong. I am not suggesting

we shouldn’t be putting a lot of emphasis on what we do if there

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is an outbreak. That is an absolutely critical part of the plan. But

given the cost in lives and dollars of what an outbreak would

mean, it just seems to me we should do everything humanly possible to prevent that spread.

Let me just ask you about the ability of the HHS to respond generally to an outbreak, and your capacity to do that in the delivery

system that has been raised, because as I understand in the National Response Plan, you were the lead agency with respect to

overseeing the Federal response at the medical level and health

level.

And we have seen some early efforts to respond to catastrophes.

We saw that with Hurricane Katrina. And I think there is general

agreement that the Federal response over all—I am not talking especially about the health area—but overall inadequate. And we had

some early look at that with respect to the health response earlier

with some of the hurricanes in Florida in 2004. And a report was

commissioned by the Department from someone from the CNA

Corp. I am not sure whether you’re familiar with that report. But

its findings were that the Department was not prepared. And looking at a case study in response to those Florida hurricanes in 2004,

it found that despite the agency’s role as a coordinator, HHS is not

viewed as a leader of the health and medical operations in the

field; often sends inexperienced junior staff members. And the report states that HHS had a, ‘‘poor working relationship with key

medical personnel from the Department of Homeland Security.’’

No. 1, are you familiar with the report and its findings? And, if

so, have any actions been taken within the Department in response

to the recommendations and findings in that report?

Secretary LEAVITT. I am not familiar with the report, and I will

tell you that is inconsistent with my own experience. We lack perfection, but I will suggest that during Katrina in particular the

medical response—not just HHS, but from the medical community

in general—was, I thought, quite remarkable.

Mr. VAN HOLLEN. Well, Mr. Secretary, I have a copy of the report

here. And, Mr. Chairman, I think it might be worthwhile for your

folks to at least brief some of the committee staff and other

interested——

Chairman TOM DAVIS [presiding]. That would be helpful, thank

you, Mr. Van Hollen.

Thank you very much. Mr. Kanjorski.

Mr. KANJORSKI. Thank you, Mr. Chairman. I don’t know whether

there is any truth to it. Of course I am watching some of the national news programs that indicate that most of the industrial nations of the world are ahead of us in the preparation for a pandemic. Is that a reasonable conclusion?

Secretary LEAVITT. I believe that is not the case, Congressman.

I think, if you would, I have met with all of the health ministers

from all the major countries many—several times on this issue.

And we are following parallel tracks. And I would tell you with respect to the fact that we have a vaccine, we are leading in the development of the vaccine. We are now sharing our technology with

other nations and working to collaborate with them. Others have

made orders of Tamiflu, like we have, and they wait for their supply in the same way we do. I would say there is no nation on Earth

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that is particularly well prepared right now. But we are better prepared today than we were yesterday, and we intend to be better

prepared tomorrow than we are today.

Mr. KANJORSKI. Mr. Secretary, in listening to the President’s program and some of the testimony even here today, it strikes me that

we are trying to resolve this problem within an existing culture of

our economy and how it operates. We are looking at whether or not

it is advantageous for companies to invest in this. It is a decisionmaking process for profit.

If, in fact, we are talking about something that could kill 100,

200, 300 million people in the world and several millions in the

United States, it seems to me one of the largest challenges in modern time that we will have faced, and it would necessitate breaking

the limitations of our—of the normal way we do business. And it

seems that everything I am hearing is that we are trying to make

sure we incentivize people, the drug companies; and they are not

listening, they are not making enough profit.

I think back to if we had decided to stay within that system to

invent the atom bomb, we couldn’t have done it in 3 or 4 years. It

would have taken us 20 years. And this may be something that necessitates a Manhattan-type Project. And the thing that brothers

me in listening to this cell culture development—and I am all for

it; I think the faster you can put a vaccine out to respond to an

emergency or a situation, the better off you are.

I have a hard time believing when I hear 5 years and everybody—well, unless, it is the technology might not be developed sufficiently to commercialize it in time? Or what is the problem? Why

should it take 5 years to implement manufacturing capacity of this

cell-culture alternative, unless it is experimental and we are still

in the process of developing? Have we developed? If we have, why

can’t we implement it in a matter of a year or two?

Secretary LEAVITT. I am going to ask Dr. Fauci, who is deeply

and personally involved in this, to respond to that.

Dr. FAUCI. Using cell culture-based techniques to develop vaccines is not new. It is successfully used in other vaccines. To adapt

it to influenza has not been easy from a number of standpoints.

The cell lines that have initially been involved at this point in time

are not particularly good yielders of virus in the sense of the yield

of growing the virus in the cell lines compared to the egg-based.

The other is that what you have is a situation where companies,

if they—and that gets into the incentive. And I appreciate what

you’re saying, sir, about the idea when you have an emergent situation, you have to go beyond incentives. But we had to deal with

companies who are very tried and true in their egg-based culture

to begin with. To get them to switch over is not an easy thing.

Mr. KANJORSKI. And that is what I sense, that we are trying to

do this with an economic system that deals with normality rather

than abnormality. And it seems to me it is going to be hard to tell

people that they have lost their children or their grandparents or

their friends or themselves, because, gee, it just wasn’t—just didn’t

fit the capital structure that the American economy is based on.

And we couldn’t entice some of these manufacturers that would

love to make an aspirin and make a lot more money on that than

a vaccine.

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I am suggesting why haven’t you come forth with setting up a

government-sponsored enterprise we put up the manufacturing capacity, we pay for it, so we can move? So that everything is going

concurrently, you’re developing the strains, and how you pick up

that efficiency could occur while we are building a manufacturing

facility. But it seems to me we are lollygoggling around, if you will,

and we are just saying, well, we probably have 5 years. And we

hope we do. And some of the people I listen to say we may have

5 or 10 years.

But what if we had had only 2 years and what if we had had

a Manhattan Project, we could have put the capacity in place, we

could have been ready, and we could have done it even governmentally? Why are you all——

Dr. FAUCI. First of all, with respect, sir, I don’t think you could

have a one-to-one relationship to say that if we don’t get cell-based

cultures next year as opposed to this year, or 2 years from now as

opposed to 3 years from now, that is going to be the whole story

of whether we are successful or not. It is not that simple and

straightforward.

Mr. KANJORSKI. If we don’t have sufficient vaccines, not only for

the American population but for the world population, if we think

we have suffered in Iraq, when we try and say we are not going

to give to the rest of the world because we don’t have enough—I

mean, this country has suffered enough dissatisfaction from the

rest of the world. We have to start thinking globally. We have a

responsibility. But here we are talking about capacity to manufacture; something that should be American. We should be No. 1. I

can’t understand why you don’t come forward and say, look, if we

can’t convince some of these companies—some of which are—one of

which, the major producer of this, is in my district. And, you know,

if they need infusion of capital to expand, let’s do what we do for

the military, let’s buy them the equipment.

Dr. FAUCI. If you look at the plan——

Mr. KANJORSKI. Doctor, what I am so worried about is everybody

talking about this magnificent plan that has been structured to operate over 5 years. And I am saying we may not have 5 years.

What is the fastest period of time we could do it? What would

it cost? And how efficient could we do it? And do we need the CDC

or somebody to be the government-sponsored enterprise to get this

done?

And it is not only a one-use thing. We are not only doing it

against this flu. We know that we are going to have diseases like

this in the future that we have to meet with a vaccine. Why not

have the capacity within the government to do that?

Secretary LEAVITT. Mr. Chairman, I think Dr. Raub, again,

would have an insightful response.

Chairman TOM DAVIS. And then we will move to Mr. Cummings

as our last question. Thank you, Dr. Raub.

Mr. RAUB. Sir, in many ways you have summarized the budget

proposal that accompanies the plan that we discussed with the two

appropriations subcommittees yesterday. The President is proposing $4.7 billion worth for that kind of incentive to revitalize the

vaccine industry for domestic production for the very reasons you’re

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saying: to try to give an acceleration such that the limiting factor

will be the technology rather than the investment decisions.

We are proposing a substantial sharing of risk between the Federal Government and this industry as a way to transform that

landscape.

Mr. KANJORSKI. And I appreciate that. But all I am suggesting

is that it sounds to me as though it is the regular order of how we

do things. And it doesn’t quite have the emphasis that I think one

of these days all of us are going to be up here asking why didn’t

we do this and why did we lose a million people when we didn’t

have to? And if the technology is there, if cell culture works, let’s

do it and do it as fast and as soon as we can, regardless of what

the expense will be.

And I am not talking about throwing money away. I am talking

about, look, we own munitions plants to develop certain munitions

that aren’t manufactured in this country. If we can do that for war,

why can’t we consider this a war on disease and spend a couple billion dollars to accomplish that?

Chairman TOM DAVIS. Thank you. Gentleman’s time has expired.

But thank you for your comments.

Mr. Cummings, 5 minutes.

Mr. CUMMINGS. Thank you very much, Mr. Chairman. I just

want to go back to the opening statement of my good friend, Mr.

Duncan, an hour or 2 ago. And he questioned whether or not this

is—we are doing overkill. In other words, whether the problem is

not as bad as the kind of cures that we are trying to come up with;

in other words, the efforts that we are putting forth.

Do you all think that we are under or overestimating the problem, the significance of this problem?

Secretary LEAVITT. Congressman, it is my belief it is a very serious problem and it is one that could have such profound impact on

our country and the world that we absolutely have to respond and

be ready.

Now, I don’t have any certainty that it is going to occur. But I

do know that if we proceed forward on the plan that we have laid

out, that at the conclusion we will have cell-based technology. We

will have the capacity for annual flu vaccine manufacturing that

we don’t have. We will have better prepared State and local governments for whatever the medical emergency should be, whether

it is a pandemic or bioterrorism event or a nuclear event.

And we will have a bio—a disease surveillance system internationally unlike what we have today. And we will have the peace

of mind of knowing we are ready for it, because it will in fact happen. Pandemics occur, and they will occur in the future just as they

have in the past.

Mr. CUMMINGS. One of the things I want to just go back to my

friend, Mr. Van Hollen, and some issues that he raised with regard

to the international situation, Mr. Secretary. You know, the Food

and Agricultural Organization of the U.N. Director said—and I

want to quote—he said, countries at risk in the international community need to act rapidly to control avian influenza at source, in

animals. We cannot afford to wait to battle the disease in pharmacies and hospitals, but we need to get rid of the virus in affected

farmers’ backyards. Prevention will be cheaper than the cure.

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And then we have the New York Times article entitled ‘‘Poverty

and Superstition and the Drive to Block Bird Flu at the Source.’’

And I quote them: ‘‘A Cambodian farmer stopped by the clinic late

one morning to pick up medicine for a chronic cough. He said if any

of his chickens fell sick, he would not tell anyone for fear the government might arrange for the rest to be slaughtered without compensation. If they were very sick—and this is the farmer talking—

before they died, then I might throw them in the brush, he said.

But if they were only a little sick, I would probably eat them.’’

To what extent, if any, are you working to address this troubling

reality, that farmers in the epicenter of this struggle have an economic disincentive to report avian flu contamination among their

animals?

Secretary LEAVITT. Congressman, I sat in the living room or the

family area of a man who did exactly that, who depended on——

Mr. CUMMINGS. Where was that, Mr. Secretary?

Secretary LEAVITT. It was in Vietnam. He and his family had 300

chickens. They depended heavily on them both for protein and for

their livelihood.

And when their village got H5N1, five of his chickens died, and

the village committee concluded they needed to kill the chickens.

He did. He had only lost five of them, and he decided he needed

to eat the others or at least invite his family over. And a week

later, he got a very serious cough and a fever and nausea, and

within 2 hours he was debilitated and headed for death. I asked

his wife about the experience. And she told me that it was obviously a terrible moment in their lives. And she was looking for

ways that she could raise money to keep his treatment going, and

they had sold the only thing they had, which was chickens.

Now, I know the cross-pressures that you’re speaking of and they

are deep and they are all over Southeast Asia. Vietnam alone has,

I think, 43 million farmers. Several million of them have chickens.

In China there are 13.5 billion chickens.

This is a problem that may have already gone beyond our capacity to contain among animals. I don’t know that with certainty, but

it is part of the equation that we have to factor in. It is primarily

an animal disease right now.

And for that, we can be grateful. And we need to move aggressively to contribute to the efforts that you’ve alluded to.

I will tell you that the head of animal health for the U.N. and

for the World Animal Health Organization was with me on that

trip. And we spent a lot of time walking through markets and dealing with the Health Ministers and the Agriculture Ministers from

those nations who are perplexed by this.

Is it possible for the United States to be involved in compensating farmers? We will be. We will be helping them in other countries

in culling their chickens. We will be helping them vaccinate. But

I did not leave there with any sense of certainty or optimism that

we would, through those efforts, be able to prevent a pandemic

should the virus mutate. We don’t know anything about what is

going on in Burma. We haven’t got a clue about what is going on

in North Korea. There are major sectors of the Earth in Africa

where we don’t have sufficient surveillance, nor do they.

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This is a tough problem. And ultimately if it makes that transition, it will become a human problem. And that is why we are taking this so seriously, to answer your first question.

Mr. CUMMINGS. Just one last question, Mr. Chairman. You know,

as you just described, just based upon what you just said, it seems

as if this is a problem that we don’t have a lot of control over. I

mean, am I right? Just going back to Mr. Van Hollen’s concern that

it is better to try to address this outside the country than inside

the country, just based upon what you just said, it seems like it

is almost an impossible task. And correct me if I’m wrong to try

to address those farmers, because they seem to be on the first line

of problems.

Secretary LEAVITT. If this makes a transition from an animal/

bird disease to a human, there will be a spark. And if we are there,

we will have an opportunity to contain it. But if it happens in a

way that happens in a place, a massive urban city where people

live close together with their animals and it spreads like wildfire,

we will not have the ability to contain it. And our doctrine calls for

us to begin containing it every other way we can, which we will

begin to do things we talked about earlier in this hearing. There

will need to be at that point provisions taken to do everything we

can to keep it off the shores of the United States. If it doesn’t, we

need a surveillance system that will help us determine when it begins to manifest itself here, and where.

That is what this plan is about. That is why this is such a serious, difficult complex problem. And we all hope it doesn’t make

that transition. But if it does, we need to be ready. And if H5N1

isn’t the virus, there will be another, and we need to be ready then.

Mr. CUMMINGS. Thank you, Mr. Chairman, Mr. Secretary.

Chairman TOM DAVIS. I thank the members for their questions.

Mr. Secretary, you did a great job. Thank you and your team and

keep up the good work.

The hearing is adjourned.

[Whereupon, at 12:45 p.m., the committee was adjourned.]

[The prepared statements of Hon. Jon C. Porter and Hon. Jean

Schmidt, and additional information submitted for the hearing

record follows:]

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